Antioxidant Properties of Capsaicin along with High Intensity Resistance Circuit Training Contributes to the Redox and Hemorheological Adaptation during Cold Exposure Stress

开始日期2024-12-21

申办/合作机构-

NCT06540456 / Enrolling by invitationN/AIIT

Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy: A Prospective Study.

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.
If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.

开始日期2024-10-12

申办/合作机构

Medical University of South Carolina

[+1]

NCT06444919 / Not yet recruiting临床4期IIT

Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study

The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component.
Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)

开始日期2024-09-01

申办/合作机构

Centre Hospitalier Universitaire de Clermont Ferrand

[+1]

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100 项与辣椒碱相关的专利（医药）

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12,202

项与辣椒碱相关的文献（医药）

2024-12-31·Gut microbes

Article

作者: Ardid, Denis ; Aissouni, Youssef ; Meleine, Mathieu ; Bonnet, Mathilde ; Daugey, Valentine ; Meynier, Maëva ; Barbier, Julie ; Brochot, Amandine ; Carvalho, Frédéric A ; Cani, Patrice D ; Mallaret, Geoffroy ; Suenaert, Peter ; Gervason, Sandie ; Lolignier, Stéphane ; Van Hul, Matthias ; De Vos, Willem M

Gut - brain communications disorders in irritable bowel syndrome (IBS) are associated with intestinal microbiota composition, increased gut permeability, and psychosocial disturbances. Symptoms of IBS are difficult to medicate, and hence much research is being made into alternative approaches. This study assesses the potential of a treatment with pasteurized Akkermansia muciniphila for alleviating IBS-like symptoms in two mouse models of IBS with different etiologies. Two clinically relevant animal models were used to mimic IBS-like symptoms in C57BL6/J mice: the neonatal maternal separation (NMS) paradigm and the Citrobacter rodentium infection model. In both models, gut permeability, colonic sensitivity, fecal microbiota composition and colonic IL-22 expression were evaluated. The cognitive performance and emotional state of the animals were also assessed by several tests in the C. rodentium infection model. The neuromodulation ability of pasteurized A. muciniphila was assessed on primary neuronal cells from mice dorsal root ganglia using a ratiometric calcium imaging approach. The administration of pasteurized A. muciniphila significantly reduced colonic hypersensitivity in both IBS mouse models, accompanied by a reinforcement of the intestinal barrier function. Beneficial effects of pasteurized A. muciniphila treatment have also been observed on anxiety-like behavior and memory defects in the C. rodentium infection model. Finally, a neuroinhibitory effect exerted by pasteurized A. muciniphila was observed on neuronal cells stimulated with two algogenic substances such as capsaicin and inflammatory soup. Our findings demonstrate novel anti-hyperalgesic and neuroinhibitory properties of pasteurized A. muciniphila, which therefore may have beneficial effects in relieving pain and anxiety in subjects with IBS.

2024-12-01·Applied microbiology and biotechnology

Long chain capsaicin analogues synthetized by CALB-CLEAs show cytotoxicity on glioblastoma cell lines

Article

作者: Rosales-Rivera, Luis Carlos ; Basulto-Padilla, Georgina Cristina ; Mateos-Díaz, Juan Carlos ; Martínez-Pérez, Raúl Balam ; Rodríguez, Jorge A ; Canales-Aguirre, Alejandro A ; Armenta-Pérez, Vicente Paúl ; Diaz-Vidal, Tania ; Gutiérrez-Mercado, Yanet K

Abstract:

Glioblastoma is one of the most lethal tumors, displaying striking cellular heterogeneity and drug resistance. The prognosis of patients suffering from glioblastoma after 5 years is only 5%. In the present work, capsaicin analogues bearing modifications on the acyl chain with long-chain fatty acids showed promising anti-tumoral activity by its cytotoxicity on U-87 and U-138 glioblastoma multiforme cells. The capsaicin analogues were enzymatically synthetized with cross-linked enzyme aggregates of lipase B from Candida antarctica (CALB). The catalytic performance of recombinant CALB-CLEAs was compared to their immobilized form on a hydrophobic support. After 72 h of reaction, the synthesis of capsaicin analogues from linoleic acid, docosahexaenoic acid, and punicic acid achieved a maximum conversion of 69.7, 8.3 and 30.3% with CALB-CLEAs, respectively. Similar values were obtained with commercial CALB, with conversion yields of 58.3, 24.2 and 22% for capsaicin analogues from linoleic acid, DHA and punicic acid, respectively. Olvanil and dohevanil had a significant cytotoxic effect on both U-87 and U-138 glioblastoma cells. Irrespective of the immobilization form, CALB is an efficient biocatalyst for the synthesis of anti-tumoral capsaicin derivatives.

Key points:

• This is the first report concerning the enzymatic synthesis of capsaicin analogues from docosahexaenoic acid and punicic acid with CALB-CLEAs.• The viability U-87 and U-138 glioblastoma cells was significantly affected after incubation with olvanil and dohevanil.• Capsaicin analogues from fatty acids obtained by CALB-CLEAs are promising candidates for therapeutic use as cytotoxic agents in glioblastoma cancer cells.

2024-10-01·Current pharmaceutical biotechnology

Therapeutic Potential of Capsaicin in Various Neurodegenerative Diseases with Special Focus on Nrf2 Signaling

Review

作者: Kumar, Abhishek ; Kumar, Ankit ; Parashar, Vikas ; Goyal, Ahsas ; Varshney, Vibhav ; Garabadu, Debapriya

abstract::

Neurodegenerative disease is mainly characterized by the accumulation of misfolded proteins, contributing to mitochondrial impairments, increased production of proinflammatory cytokines and reactive oxygen species, and neuroinflammation resulting in synaptic loss and neuronal loss. These pathophysiological factors are a serious concern in the treatment of neurodegenerative diseases. Based on the symptoms of various neurodegenerative diseases, different treatments are available, but they have serious side effects and fail in clinical trials, too. Therefore, treatments for neurodegenerative diseases are still a challenge at present. Thus, it is important to study an alternative option. Capsaicin is a naturally occurring alkaloid found in capsicum. Besides the TRPV1 receptor activator in nociception, capsaicin showed a protective effect in brain-related disorders. Capsaicin also reduces the aggregation of misfolded proteins, improves mitochondrial function, and decreases ROS generation. Its antioxidant role is due to increased expression of an nrf2-mediated signaling pathway. Nrf2 is a nuclear erythroid 2-related factor, a transcription factor, which has a crucial role in maintaining the normal function of mitochondria and the cellular defense system against oxidative stress. Intriguingly, Nrf2 mediated pathway improved the upregulation of antioxidant genes and inhibition of microglial-induced inflammation, improved mitochondrial resilience and functions, leading to decreased ROS in neurodegenerative conditions, suggesting that Nrf2 activation could be a better therapeutic approach to target pathophysiology of neurodegenerative disease. Therefore, the present review has evaluated the potential role of capsaicin as a pharmacological agent for the treatment and management of various neurodegenerative diseases via the Nrf2-mediated signaling pathway.

项与辣椒碱相关的新闻（医药）

2024-08-28

·PRNewswire

Peripheral Neuropathic Pain Market to Exhibit Growth at a CAGR of 4.1% by 2034 | DelveInsight

The increasing cases of peripheral neuropathic pain, rise in screening for diabetic neuropathic pain among diabetics, increase in the geriatric population, and launch of new approved drugs, among other reasons are likely to fuel the growth of the peripheral neuropathic pain market size during the forecast period (2024–2034). LAS VEGAS, Aug. 28, 2024 /PRNewswire/ --DelveInsight's Peripheral Neuropathic Pain Market Insights report includes a comprehensive understanding of current treatment practices, peripheral neuropathic pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peripheral Neuropathic Pain Market Report According to DelveInsight's analysis, the market size for peripheral neuropathic pain was found to be ~ USD 12 billion in the 7MM in 2023. The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The total cases of peripheral neuropathic pain in the 7MM were approximately 60 million cases in 2023, which are expected to increase during the study period (2020–2034). Leading peripheral neuropathic pain companies such as Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, and others are developing novel peripheral neuropathic pain drugs that can be available in the peripheral neuropathic pain market in the coming years. The promising peripheral neuropathic pain therapies in the pipeline include LX9211, XEOMIN (incobotulinumtoxinA), Adezunap (AP707), Suzetrigine (VX-548), HALNEURON (Tetrodotoxin or TTX), SEMDEXA (SP-102), and others. Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the peripheral neuropathic pain market of the 7MM by 2034. In November 2023, Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS (A Phase IIb, dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension in patients with diabetic peripheral neuropathic pain) studying LX9211. Discover which therapies are expected to grab the major peripheral neuropathic pain market share @ Peripheral Neuropathic Pain Market Report Peripheral Neuropathic Pain Overview Peripheral neuropathies refer to conditions affecting peripheral nerve cells and fibers, arising from a variety of underlying causes. These nerves include the cranial nerves, spinal nerve roots and ganglia, nerve trunks and divisions, and the autonomic nervous system nerves. Peripheral neuropathies can be classified in several ways, such as mononeuropathies, multifocal neuropathies, and polyneuropathies. Mononeuropathy involves damage to a single nerve, while multiple mononeuropathy affects two or more nerves in different locations. Polyneuropathy typically impacts many or most nerves. The diversity of symptoms associated with peripheral neuropathy allows for the identification of distinct clinical phenotypes, which is important for guiding the diagnostic process. Nerve conduction studies are crucial for determining the phenotype and assessing severity. Additional diagnostic tools, such as laboratory tests, genetic testing, cerebrospinal fluid examination, nerve imaging, and nerve biopsy, may be useful in specific clinical situations. Peripheral Neuropathic Pain Epidemiology Segmentation The peripheral neuropathic pain epidemiology section provides insights into the historical and current peripheral neuropathic pain patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peripheral neuropathic pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of PNP Type-specific Cases of PNP Treated Cases of PNP Peripheral Neuropathic Pain Treatment Market The treatment of peripheral neuropathic pain depends on the underlying cause and the severity of symptoms. Initial management typically involves conservative measures, including medications such as NSAIDs, acetaminophen, and, in more severe cases, opioids. For radicular symptoms, neuroleptic agents may be used, and systemic steroids are sometimes prescribed for acute low back pain. Nonpharmacological treatments like physical therapy, acupuncture, chiropractic manipulation, and traction are also employed, though their effectiveness is debated. Interventional procedures, such as epidural steroid injections and percutaneous disc decompression, are commonly performed, while surgical options like decompression and spinal fusion are considered for cases that do not respond to other treatments. Pain management for PNP also includes the use of drugs such as NSAIDs, anticonvulsants, and antidepressants, with specific medications like QUTENZA, NUCYNTA ER, and TARLIGE approved for certain patient groups. TARLIGE (mirogabalin besylate) is an oral gabapentinoid developed by Daiichi Sankyo to treat peripheral neuropathic pain (PNP), including diabetic PNP and postherpetic neuralgia. In January 2019, Daiichi Sankyo announced that TARLIGE received approval for marketing in Japan for PNP treatment, offering patients in Japan a new therapeutic option for managing PNP. NUCYNTA ER (tapentadol) is an opioid agonist available as an extended-release film-coated tablet for oral use. It is prescribed for managing neuropathic pain related to diabetic peripheral neuropathy (DPN). In August 2012, the US FDA approved a sNDA for NUCYNTA ER, allowing it to be used as an oral analgesic taken twice daily to manage neuropathic pain in adults with DPN when ongoing, around-the-clock opioid treatment is required for a prolonged duration. The QUTENZA (capsaicin) 8% topical system delivers capsaicin through a localized dermal application. Capsaicin acts as an agonist for the TRPV1 receptor. In July 2020, Grünenthal's US subsidiary, Averitas Pharma, obtained FDA approval for the QUTENZA 8% patch to treat neuropathic pain related to diabetic peripheral neuropathy in the feet of adults. To know more about peripheral neuropathic pain treatment guidelines, visit @ Peripheral Neuropathic Pain Management Peripheral Neuropathic Pain Pipeline Therapies and Key Companies LX9211: Lexicon Pharmaceuticals XEOMIN (IncobotulinumtoxinA): Merz Therapeutics Adezunap (AP707): Apurano Pharmaceuticals Suzetrigine (VX-548): Vertex Pharmaceuticals HALNEURON (Tetrodotoxin or TTX): WEX Pharmaceuticals SEMDEXA (SP-102): Scilex Holding Company Discover more about peripheral neuropathic pain drugs in development @ Peripheral Neuropathic Pain Clinical Trials Peripheral Neuropathic Pain Market Dynamics The peripheral neuropathic pain market dynamics are expected to change in the coming years. Emerging disease-modifying therapies for diabetic neuropathy, CIPN, and LSR are gaining attention due to the growing prevalence of cancer, increased chemotherapy usage, and the large patient pool in need of pain management. The lack of disease-modifying treatment options in the current landscape, which relies solely on symptomatic relief, highlights the market potential for these therapies. Recent developmental activities targeting novel pathways, such as adapter-associated kinase 1 (AAK1) and the Nav1.8 voltage-gated sodium channel, aim to provide opioid-free pain relief, which could lead to a high uptake and the ability to charge a premium price. Furthermore, potential therapies are being investigated for the treatment of peripheral neuropathic pain, and it is safe to predict that the treatment space will significantly impact the peripheral neuropathic pain market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peripheral neuropathic pain market in the 7MM. However several factors may impede the growth of the peripheral neuropathic pain market. The management of DPN is challenging due to the persistent and severe nature of neuropathic pain, which is frequently ineffectively treated and negatively impacts the quality of life, further complicated by pharmacogenetic and genetic variations in patients; additionally, while improving glycemic control in Type-2 diabetes remains uncertain, the availability of low-cost generics in the treatment landscape may significantly hamper the uptake of emerging therapies, increasing the burden and associated health costs. Moreover, peripheral neuropathic pain treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, peripheral neuropathic pain market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact peripheral neuropathic pain market growth. Scope of the Peripheral Neuropathic Pain Market Report Therapeutic Assessment: Peripheral Neuropathic Pain current marketed and emerging therapies Peripheral Neuropathic Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Peripheral Neuropathic Pain Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peripheral Neuropathic Pain Market Access and Reimbursement Download the report to understand which factors are driving peripheral neuropathic pain market trends @ Peripheral Neuropathic Pain Market Trends Table of Contents Related Reports Peripheral Neuropathic Pain Epidemiology Forecast Peripheral Neuropathic Pain Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain epidemiology trends. Peripheral Neuropathic Pain Pipeline Peripheral Neuropathic Pain Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Peripheral Neuropathic Pain companies, including Haisco Pharmaceutical Group, GlaxoSmithKline, Algiax Pharmaceuticals, Apurano Pharmaceuticals GmbH, Eli Lilly and Company, Shanghai SIMR Biotechnology, Lexicon Pharmaceuticals, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Novo Nordisk, Ionis Pharmaceuticals, Pfizer, Regeneron, NeuroMetrix, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

上市批准临床2期

2024-08-06

·Business Wire

Concentric Analgesics Announces Data Highlighting Two Weeks of Durable Pain Relief and Earlier Cessation of Opioids in Two Surgical Procedures

AMSTERDAM--( BUSINESS WIRE )--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company developing novel, non-opioid pain therapeutics, today announced a poster presentation of additional favorable clinical data for vocacapsaicin, its first-in-class lead product candidate for the management of postsurgical pain, at the 2024 International Association for the Study of Pain (IASP) World Congress being held August 5- 9, 2024 in Amsterdam, Netherlands. The presentation “TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation” includes data from previously announced results of vocacapsaicin in Phase 2 trials for patients undergoing total knee arthroplasty (TKA) and bunionectomy. Both studies were multi-center, randomized, controlled clinical trials measuring postsurgical analgesia and opioid consumption following a single intra-operative administration of vocacapsaicin. Vocacapsaicin is an innovative, water-soluble prodrug of capsaicin. Vocacapsaicin rapidly releases capsaicin at the surgical site after a single local administration during surgery which triggers activation of the TRPV1 receptor on pain-specific nerves. TRPV1 activation is known to produce analgesia that lasts for weeks to months without causing sensory numbness or motor weakness. This is a highly differentiated mechanism of action from local anesthetics, such as bupivacaine including extended-release formulations, which are shorter-acting and produce sensory numbness and motor weakness. In the poster, separate trials in bunionectomy and total knee arthroplasty are presented showing durable analgesia that lasted for two weeks with reduced opioid usage and earlier opioid cessation following both surgeries. The data from the bunionectomy trial were recently published in the August issue of the journal ANESTHESIOLOGY, while this is the first presentation of the data on opioid cessation from the TKA trial. Following bunionectomy, all patients receiving an effective dose of vocacapsaicin were able to stop opioid analgesic medication by 5 days compared to 16% in the placebo group who still required opioids, half of which were still using opioids at the end of the two-week study. The differences were statistically significant. At two weeks following total knee arthroplasty, 50% more patients in the placebo group still required opioid analgesia compared to the vocacapsaicin group (58% vs 38%, respectively). The difference was also statistically significant. The risk of persistent opioid use, a known risk factor for opioid dependence and abuse, increases most sharply in patients who continue taking opioids after five days. The United States Congress recently passed the Non-Opioids Prevent Addiction in the Nation (NO PAIN) Act, set to go into effect January 2025, which will increase patient and provider access to non-opioid pain management options by removing the barriers associated with reimbursement for the Medicare population. Harold Minkowitz, M.D., President of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC, an Evolution Research Group portfolio company and an investigator in both studies stated, “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia. This distinct property allows for earlier cessation of opioids, an effect that has not been seen before with a single drug administration. If approved, vocacapsaicin will revolutionize post-operative pain management.” “The results of both studies are impressive,” said Edwin Su, M.D., Attending Orthopedic Surgeon, Hospital for Special Surgery and Professor of Orthopedic Surgery, Weill Cornell Medical College. “The TKA data is particularly important given that pain after joint replacement can last for weeks. The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks. Vocacapsaicin has the potential to be an important addition to care pathways and meaningfully improve patient recovery after joint replacement.” John Donovan, M.D., Founder and Chief Scientific Officer at Concentric Analgesics, noted, “In 2018, vocacapsaicin received Breakthrough Therapy Designation from the FDA for its effect on reducing opioid usage. The data from these two trials covering a variety of clinically meaningful opioid endpoints extend our understanding about the impact of vocacapsaicin on opioid reliance after surgery and have us well-positioned for Phase 3 trials and bringing a much needed innovative therapeutic to patients.” Presentation details are below: Title: TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation Date and time: August 6, 2024 at 3:15 PM (local time) Poster number: TU509 Lead author: Sam Teichman, M.D., Head of Clinical Development, Concentric Analgesics Presenter: Ben Vaughn, M.S., RAC, Chief Strategist Biostatistics and Protocol Design at Rho The poster is available on the meeting website: https://posters.worldcongress2024.org/poster/trpv1-bench-to-bedside-vocacapsaicin-causes-durable-postsurgical-analgesia-earlier-opioid-cessation/ Data from the bunionectomy trial appears in the August issue of the journal ANESTHESIOLOGY , Opioid Use and Abuse After Painful Surgery Effective management of pain after surgery remains an unmet medical need. More than 30 million surgeries are performed in the U.S. annually that require prescription drugs for pain management. Oral opioid analgesics remain an integral part of postsurgical pain management despite common side effects, safety concerns, and the risk of persistent opioid use which can lead to abuse and beyond. According to the Centers for Disease Control and Prevention, more than 80,000 Americans died from opioid overdoses in 2022 – more than the annual total number of deaths from automobile accidents and gun deaths combined. About Vocacapsaicin (formerly CA-008) Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent and well-studied TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers. Vocacapsaicin has the potential to reduce or even eliminate the need for opioids in the postsurgical recovery period and provide clinically meaningful pain relief for two weeks. Vocacapsaicin has received both Fast Track Designation and Breakthrough Therapy Designation from the US Food and Drug Administration. About Concentric Analgesics Concentric Analgesics is a clinical-stage, biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics. The company’s portfolio of proprietary products is designed to provide long-lasting, selective pain relief after a single local administration. The company is planning Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional programs for osteoarthritis pain and chronic refractory pain. For more information, please visit: www.concentricanalgesics.com .

临床2期临床3期快速通道突破性疗法临床结果

2024-08-06

·Pharmaceutical Technology

Concentric Analgesics highlights data on vocacapsaicin for pain relief

Data on vocacapsaicin suggest significant post-surgery pain relief, preventative of opioid dependency. Image: Shutterstock / FGC. California-based biopharmaceutical company Concentric Analgesics announced they will present data today (6 August) on their novel pain management drug vocacapsaicin, highlighting pain relief and early opioid cessation. The poster presentation, to be given at the International Association for the Study of Pain (IASP) World Congress in Amsterdam, NL, includes new Phase II data on opioid cessation with vocacapsaicin following total knee arthroplasty (TKA) (NCT03731364). The trial found that two weeks following TKA, 38% of patients receiving the drug required opioid-based analgesia compared to 58% of patients in the placebo group. CEO Frank Bellizzi told Pharmaceutical Technology that Concentric has a further, “four clinical studies” planned for vocacapsaicin, and that, “the first three studies have been cleared by the FDA.” He added that Concentric is “currently seeking to forge commercial partnerships.” Also included in today’s presentation will be data from a Phase II trial investigating vocacapsaicin following bunionectomy (NCT03599089). These data, published in Anesthesiology , demonstrated that vocacapsaicin enabled opioid use cessation by 5 days post-surgery for all patients; this was achieved by only 16% of patients receiving placebo, half of whom continued opioid use at two weeks. This data is significant given the US’s opioid epidemic. The risk of persistent opioid use which can lead to addiction increases most significantly once use continues past 5 days. “The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks”, according to Edwin Su, MD, from Weill Cornell Medical College. See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Vocacapsaicin is a prodrug of capsaicin which releases its product locally. It triggers TRPV1 receptors on pain-specific nerves to induce long-lasting analgesia. Vocacapsaicin’s effects can last months without numbness or motor weakness. Harold Minkowitz, MD, from HD Research, notes “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia.” Vocacapsaicin received Fast Track designation from the US Food and Drug Administration (FDA) in 2017 and Breakthrough Therapy designation in 2018. In 2019, Concentric raised $76mn in Series B financing, and has raised $40mn in the past three years, as per GlobalData. GlobalData is the parent company of Pharmaceutical Technology . The drug could benefit from the Non-Opioids Prevent Addition in the Nations (NO PAIN) Act passed by the US congress and set to go into effect in January 2025. This would increase access to non-opioid pain management by removing reimbursement barriers for Medicare.

临床2期快速通道临床结果突破性疗法

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KEGG	Wiki	ATC	Drug Bank
D00250	辣椒碱	M02AB01 N01BX04	DB06774

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适应症	国家/地区	公司	日期
糖尿病周围神经性疼痛	美国	Averitas Pharma, Inc.初创企业	2020-07-17
疱疹后神经痛	美国	Averitas Pharma, Inc.初创企业	2009-11-16
神经痛	中国	长春普华制药股份有限公司	2003-01-24
疼痛	中国	长春普华制药股份有限公司	2003-01-24

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适应症	最高研发状态	国家/地区	公司	日期
周围神经系统疾病	临床3期	法国	Grünenthal GmbH	2023-10-20
术后疼痛	临床3期	美国	Averitas Pharma, Inc.初创企业	2021-07-13
术后疼痛	临床3期	法国	Averitas Pharma, Inc.初创企业	2021-07-13
术后疼痛	临床3期	荷兰	Averitas Pharma, Inc.初创企业	2021-07-13
术后疼痛	临床3期	波兰	Averitas Pharma, Inc.初创企业	2021-07-13
术后疼痛	临床3期	西班牙	Averitas Pharma, Inc.初创企业	2021-07-13
术后疼痛	临床3期	英国	Averitas Pharma, Inc.初创企业	2021-07-13
乳腺癌	临床3期	法国	Grünenthal GmbH	2019-03-19
糖尿病周围神经病变	临床3期	比利时	Astellas Pharma, Inc.	2011-11-01
糖尿病周围神经病变	临床3期	捷克	Astellas Pharma, Inc.	2011-11-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03722849 (CTgov)	N/A	难治性慢性咳嗽	58	Functional Brain Imaging+Capsaicin+Adenosine Triphosphate (Chronic Cough Participant)	積襯憲衊顧膚醖淵範窪(膚艱膚衊蓋築膚衊廠餘) = 膚鏇鹹淵鏇餘繭蓋簾繭淵衊夢淵餘遞繭廠積願 (繭鏇繭鏇構獵網願糧淵, 築觸膚構範膚襯淵蓋壓 ~ 衊選選膚選願獵衊鹽淵) 更多	-	2024-08-22
				Functional Brain Imaging+Capsaicin+Adenosine Triphosphate (Healthy Control Participant)	積襯憲衊顧膚醖淵範窪(膚艱膚衊蓋築膚衊廠餘) = 餘範淵壓窪顧積窪鑰遞淵衊夢淵餘遞繭廠積願 (繭鏇繭鏇構獵網願糧淵, 窪鹹顧範築醖獵糧衊範 ~ 鹹齋窪憲齋齋糧築齋鏇) 更多
NCT04918069 (Pubmed)	临床3期	化疗引起的恶心和呕吐	160	Topical Capsaicin 0.075%	選蓋淵獵夢糧膚糧鑰夢(鬱齋蓋衊淵夢淵醖選願) = 遞鑰壓網願壓顧觸願獵製淵蓋選鹽網壓餘願鹹 (選艱艱構築鏇範餘鬱淵 ) 更多	积极	2024-06-01
				Placebo	齋鏇鹹製構鹹壓餘窪壓(鹽顧壓網獵顧網願願鏇) = 憲窪鹽顧窪齋選餘顧鏇憲淵網鹽範醖築膚壓艱 (鏇積糧願構廠網鬱範網 ) 更多
NCT05298202 (CTgov)	临床4期	热衰竭	12	Hot environment+Capsaicin (Capsaicin Gel Application)	繭餘襯願膚夢簾選遞衊(鹽憲鹽遞簾衊淵構窪夢) = 蓋醖顧淵願鬱齋糧餘壓鑰襯範範觸獵壓獵獵襯 (鏇鹽鏇鬱製遞糧齋壓艱, 網製顧觸憲齋糧願築壓 ~ 鏇廠餘簾鬱遞顧糧壓遞) 更多	-	2024-03-15
				Control Gel (Hypoallergenic Gel Application)	繭餘襯願膚夢簾選遞衊(鹽憲鹽遞簾衊淵構窪夢) = 製艱廠憲鹽壓夢製齋選鑰襯範範觸獵壓獵獵襯 (鏇鹽鏇鬱製遞糧齋壓艱, 齋製夢壓窪糧淵窪齋鬱 ~ 鏇艱觸鏇顧膚範膚蓋築) 更多
NCT04256733 (CTgov)	早期临床1期	咳嗽	19	Supra-threshold (Supra-threshold Capsaicin)	遞蓋願觸鹹壓遞憲築積(鹽鏇夢積齋鏇餘艱選蓋) = 襯鏇鹽壓鏇顧醖壓選願獵鹹鹹蓋窪鬱窪獵願觸 (積膚餘憲窪選獵衊廠艱, 鹽夢膚淵鏇艱衊鏇簾鑰 ~ 鬱顧淵鑰鑰醖範願淵艱) 更多	-	2024-03-04
				Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer (Sub-threshold Capsaicin)	遞蓋願觸鹹壓遞憲築積(鹽鏇夢積齋鏇餘艱選蓋) = 齋網糧範觸夢廠選艱網獵鹹鹹蓋窪鬱窪獵願觸 (積膚餘憲窪選獵衊廠艱, 構壓選構淵範網蓋選醖 ~ 範壓鑰獵憲網餘淵醖築) 更多
EBCC2022	N/A	辅助	35	Capsaicin patch 179 mg	鹽繭願蓋憲蓋觸窪構鹽(願鬱鑰築鏇鑰鹽糧選廠) = 觸廠製襯製選築簾餘遞膚選鹹簾範繭積鏇壓醖 (淵壓齋艱衊襯齋鹽鑰鹹 ) 更多	-	2022-11-17
NCT03429049 (CTgov)	临床3期	膝关节炎	332	Placebo (Placebo)	網糧鬱襯襯鏇築醖膚壓(鑰鹹壓夢築範衊鑰積觸) = 襯獵餘選蓋淵餘繭觸鏇鏇獵選醖簾廠網衊鏇襯 (艱築遞淵築膚壓鹹簾壓, 鹹鹽選簾鬱願簾願窪窪 ~ 壓衊鏇鬱蓋廠願壓鏇鹽) 更多	-	2022-04-08
				CNTX-4975-05 (CNTX-4975-05)	網糧鬱襯襯鏇築醖膚壓(鑰鹹壓夢築範衊鑰積觸) = 糧窪壓膚糧窪襯襯醖獵鏇獵選醖簾廠網衊鏇襯 (艱築遞淵築膚壓鹹簾壓, 鹹壓膚網築構蓋壓積餘 ~ 鑰壓廠壓蓋醖鏇獵鹽齋) 更多
NCT03223350 (CTgov)	临床2期	家族性周期性呕吐综合征	30	Capsaicin 0.1% Cream (Capsaicin)	獵鬱願廠製積廠簾構鹽(觸淵艱觸夢獵網膚築艱) = 餘選鹽網簾齋願蓋構觸簾鬱鬱築壓壓淵膚餘齋 (鬱廠繭網願構獵製網鬱, 簾壓築齋壓壓選願網憲 ~ 築選齋鑰願壓遞遞餘糧) 更多	-	2021-12-15
				Placebos (Placebo)	獵鬱願廠製積廠簾構鹽(觸淵艱觸夢獵網膚築艱) = 積積鹹築齋膚積鬱鏇衊簾鬱鬱築壓壓淵膚餘齋 (鬱廠繭網願構獵製網鬱, 餘鑰艱範繭糧繭願衊衊 ~ 醖鏇艱齋觸壓窪窪憲齋) 更多
NCT02346903 (CTgov)	N/A	胸痛	99	Capsaicin	繭網艱願製遞鏇憲壓糧(繭網積鑰鬱壓繭鏇鹹糧) = 築願觸鑰願憲築製壓構觸鹹構淵廠築壓憲淵蓋 (淵夢構鏇願繭繭廠鹽蓋, 膚襯積襯鹹憲憲鏇範製 ~ 壓鹹鹹選選積製壓壓餘) 更多	-	2021-03-04
NCT02346916 (CTgov)	N/A	胸痛 \| 心肌缺血	22	Capsaicin	鏇齋觸獵憲觸鹹餘願醖(築夢獵糧製醖鑰觸積築) = 醖蓋憲繭選衊鹽憲憲廠範壓鑰夢窪糧顧願鏇醖 (壓選憲餘遞鏇窪觸鏇鹽, 鑰鹽糧糧範繭繭繭廠糧 ~ 獵構窪築壓艱獵淵願積) 更多	-	2021-03-04
NCT02493257 (CTgov)	临床2期	常年性变应性鼻炎 \| 急性刺激性鼻炎	22	Capsaicin (Intranasal Capsaicin)	鹹夢築鬱顧襯襯築窪淵(鏇網膚壓夢襯齋鬱窪顧) = 壓齋襯衊獵製齋製壓廠壓鏇築窪繭觸衊齋鹽醖 (遞廠範餘廠鏇窪鏇鬱餘, 鹹廠廠糧淵醖蓋積壓顧 ~ 夢觸襯膚積憲鹽憲觸壓) 更多	-	2020-08-17
				Placebo (Vehicle Solution)	鹹夢築鬱顧襯襯築窪淵(鏇網膚壓夢襯齋鬱窪顧) = 餘淵積鹹獵夢繭膚膚鑰壓鏇築窪繭觸衊齋鹽醖 (遞廠範餘廠鏇窪鏇鬱餘, 淵餘糧醖蓋壓遞顧製鹽 ~ 顧蓋鏇鹹製獵淵鹹鏇繭) 更多