Levomethadyl Acetate Hydrochloride

According to DelveInsight's analysis, the current developmental pipeline for opioid withdrawal syndrome has multiple players; several companies have initiated clinical trials investigating new treatment options or studying how to use existing treatment options better. The dynamics of the opioid withdrawal syndrome market are also anticipated to change in the coming years, owing to the rise in healthcare spending globally. LAS VEGAS, May 1, 2024 /PRNewswire/ -- DelveInsight's Opioid Withdrawal Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, opioid withdrawal syndrome 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 Opioid Withdrawal Syndrome Market Report According to DelveInsight's analysis, the market size for opioid withdrawal syndrome reached USD 1.3 billion in 2022 across the 7MM. Among the 7MM, the US captured the highest market in 2022, covering a total of 90% market, followed by the UK, which is anticipated to grow during the forecast period (2023–2034). In the US, the market mainly consisted of opioid agonist-antagonist, Alpha-2 adrenergic agonists and others, which generated nearly USD 1.1 million in 2022. According to DelveInsight estimations, nearly 9 million cases with long-term opioid usage were found in 2022 in the 7MM. Leading opioid withdrawal syndrome companies such as DemeRx IB, Inc., atai Life Sciences, MediciNova, BioXcel Therapeutics Inc., and others are developing novel opioid withdrawal syndrome drugs that can be available in the opioid withdrawal syndrome market in the coming years. The promising opioid withdrawal syndrome therapies in the pipeline include DMX-1002 (Ibogaine HCl), MN-166, BXCL501 , and others. Discover which therapies are expected to grab the major opioid withdrawal syndrome market share @ Opioid Withdrawal Syndrome Market Report Opioid Withdrawal Syndrome Overview Opioid withdrawal is a set of symptoms that occurs when opioids (such as µ-receptor agonists) are suddenly stopped, their use is reduced, or they are no longer taken for treatment. This can also happen when an opioid antagonist (like naltrexone or naloxone) or, in some cases, a partial opioid agonist (such as buprenorphine) is given to someone who has become physically dependent on opioids due to regular and persistent use. There isn't a specific test to diagnose opioid withdrawal, but it's important to conduct urine toxicology tests to rule out withdrawal from other drugs or combinations of drugs. Urine tests usually detect most opioids like morphine, heroin, codeine, oxycodone, and propoxyphene for about 12 to 36 hours after their use. However, methadone, buprenorphine, and LAAM (L-alpha-acetylmethadol) won't show up in standard urine tests for opioids and need specific testing. Additionally, urine tests for other substances like marijuana, cocaine, benzodiazepines, and amphetamines may often show positive results in opioid users. Other tests such as ECG, complete blood count (CBC), blood alcohol levels, and basic metabolic panel (BMP) should also be conducted. The severity of opioid withdrawal is commonly assessed using the Clinical Opioid Withdrawal Scale (COWS). Opioid Withdrawal Syndrome Epidemiology Segmentation As per DelveInsight's estimations, the total number of cases with opioid withdrawal syndrome in the United States were approximately 7 million in 2022 and are projected to decrease during the forecast period. The opioid withdrawal syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Number of Opioid Misuse Cases Number of Cases with Long-term Opioid Usage Total Opioid Withdrawal Symptoms Cases Opioid Withdrawal Syndrome Treatment Market The management of opioid use disorder and opioid withdrawal syndrome are intricately linked since they tackle various facets of the same fundamental problem: dependency on opioids and the difficulties it brings. Opioid use disorder treatment is centered on enduring control and recovery from opioid addiction, whereas opioid withdrawal syndrome treatment mainly deals with the immediate symptoms that emerge when people try to lessen or stop their opioid use. A successful approach to handling OWS is frequently a vital part of OUD treatment, especially during the detoxification stage when individuals might undergo severe withdrawal symptoms. Drugs employed to ease OWS can also contribute to treating OUD by aiding individuals in moving from reliance on opioids towards stability and eventual abstinence. These medications not only alleviate withdrawal signs but also diminish cravings, facilitating individuals' participation in behavioral therapies and other components of comprehensive OUD treatment. The management strategy for OWS varies depending on how severe the symptoms are for the person. When the withdrawal symptoms are mild, patients are advised to focus on staying hydrated by drinking at least 2–3 liters of water each day. Additionally, taking vitamin B and C supplements may be helpful in maintaining overall health. Generally, managing mild symptoms involves providing symptomatic treatment and supportive care, aiming to ease discomfort and ensure the patient's well-being during this period. In instances of greater severity, drugs such as methadone or codeine phosphate might be contemplated, especially for those needing detoxification from opioids with longer-lasting effects. These medications can ease withdrawal symptoms and diminish cravings, but cautious supervision and dosage adjustments are vital to ensure safety and efficacy. To know more about opioid withdrawal syndrome treatment guidelines, visit @ Opioid Withdrawal Syndrome Management Opioid Withdrawal Syndrome Pipeline Therapies and Key Companies DMX-1002 (Ibogaine HCl): DemeRx IB, Inc./atai Life Sciences MN-166: MediciNova BXCL501: BioXcel Therapeutics Inc. Learn more about the FDA-approved drugs for opioid withdrawal syndrome @ Drugs for Opioid Withdrawal Syndrome Treatment Opioid Withdrawal Syndrome Market Dynamics The dynamics of the opioid withdrawal syndrome market are expected to change in the coming years. Globally, the recognition of the opioid crisis and the necessity for effective treatments, including medications and behavioral therapies, has prompted pharmaceutical companies to invest in research and development, while government initiatives prioritize opioid withdrawal management, fostering opioid withdrawal syndrome market growth and opportunities for companies. The shift towards precision medicine also offers possibilities for developing targeted treatments, addressing the high prevalence of opioid addiction, and creating significant market demand for withdrawal syndrome treatments, potentially leading to substantial growth with the introduction of therapies featuring novel mechanisms, alongside the dominance of buprenorphine-based products in the current and emerging opioid withdrawal syndrome market. Furthermore, many potential therapies are being investigated for the treatment of opioid withdrawal syndrome, and it is safe to predict that the treatment space will significantly impact the opioid withdrawal syndrome 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 opioid withdrawal syndrome market in the 7MM. However several factors may impede the growth of the opioid withdrawal syndrome market. The stigma surrounding opioid addiction and withdrawal persists, potentially dissuading individuals from pursuing treatment or utilizing the resources available to them, despite advancements. The range of treatments for opioid withdrawal syndrome is still somewhat limited, necessitating more effective and accessible options. Stringent regulatory requirements and lengthy approval processes could delay the introduction of new OWS therapies to the market, hampering innovation, while economic downturns or changes in healthcare policies might impact funding for opioid addiction treatment programs and access to care, posing a threat to the OWS market and potentially compromising patient care and therapeutic effectiveness. Moreover, opioid withdrawal syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the opioid withdrawal syndrome 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 the opioid withdrawal syndrome market growth. Scope of the Opioid Withdrawal Syndrome Market Report Therapeutic Assessment: Opioid Withdrawal Syndrome current marketed and emerging therapies Opioid Withdrawal Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Opioid Withdrawal Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Opioid Withdrawal Syndrome Market Access and Reimbursement Discover more about opioid withdrawal syndrome drugs in development @ Opioid Withdrawal Syndrome Clinical Trials Table of Contents Related Reports Opioid Withdrawal Syndrome Pipeline Opioid Withdrawal Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key opioid withdrawal syndrome companies, including Chiesi Farmaceutici S.p.A., BioXcel Therapeutics, Aphios Pharmaceutical, among others. Opioid Withdrawal Syndrome Epidemiology Opioid Withdrawal Syndrome Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted opioid withdrawal syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Opioid Use Disorder Market Opioid Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key opioid use disorder companies, including Braeburn Pharmaceuticals, BioXcel Therapeutics, MediciNova, AstraZeneca, Cerevel Therapeutics, LLC, Indivior Inc., Aptinyx, among others. Opioid Dependence Market Opioid Dependence Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key opioid dependence companies, including GW Pharmaceuticals, Opiant Pharmaceuticals, ATAI Life Sciences, C4X Discovery, 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

STAMFORD, Conn.--(BUSINESS WIRE)-- Purdue Pharmaceuticals, L.P.. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*. If the auto-injector is approved, it would be the second nalmefene-containing medicine developed by Purdue to specifically address the growing number of opioid overdose deaths, including those due to fentanyl and other synthetic opioids. It would be the first nalmefene medicine available as an auto-injector. Purdue developed the nalmefene auto-injector because it is a type of device familiar to the U.S. population through experience with similar devices on the market used for severe allergic reactions. If approved, the nalmefene auto-injector could be used by healthcare professionals and first responders, as well as laypersons without medical training such as bystanders, caregivers, or family members. “As part of our Public Health Initiatives, we are committed to providing essential opioid overdose treatments to help save lives in our communities,” said Craig Landau, MD, President and CEO, Purdue. "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals. If approved, we would distribute this medication for no profit, as part of our commitment to help abate the opioid crisis.” FDA has granted a priority review for the NDA and assigned a goal date of August 7, 2024. Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition. Purdue currently distributes, at no profit, nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL), an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected opioid overdose.1 Healthcare professionals can learn more about injectable nalmefene at . *This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that nalmefene autoinjector will successfully complete development or gain FDA approval. IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose. CONTRAINDICATION Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product. WARNINGS AND PRECAUTIONS Use of Nalmefene Hydrochloride injection in Emergencies Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access. Risk of Recurrent Respiratory Depression Accidental overdose with long acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment. Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression. Cardiovascular Risks with Narcotic Antagonists Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects. Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs. Risk of Precipitated Withdrawal Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications. Incomplete Reversal of Buprenorphine Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphine-induced respiratory depression. Use in Pediatric Patients Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established. ADVERSE REACTIONS The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%). To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or . Please read Prescribing Information available here. For more information, visit . About Purdue Pharma L.P. Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. Purdue’s plan of reorganization will deliver billions in value to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants. Substantially all of Purdue’s assets will be transferred to a new post-emergence company with a public-minded mission. This new company will be governed by new independent board members and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients who rely on its medicines, pursuing its pipeline and introducing medicines that will help save and improve lives. For more information, visit . References Nalmefene Hydrochloride Injection 2mg/2mL (1mg/1mL) [Full Prescribing Information]. Stamford, CT: Purdue Pharma L.P., 02/08/2022. . Accessed February 14, 2024. MR-08523