A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

开始日期2015-12-01

申办/合作机构

Promius Pharma LLC

NCT02445807 / Completed临床3期

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis for 14 Days

This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.

开始日期2015-12-01

申办/合作机构

Promius Pharma LLC

EUCTR2015-003804-21-DE / Not yet recruiting临床2期

Multi-centre, Randomized, Double-blind, Placebo-Controlled Pilot Safety and Efficacy Study of 8 Weeks of Treatment with DFD-07 for Actinic Keratosis of the Face and Scalp

开始日期2015-11-12

申办/合作机构

Promius Pharma LLC

100 项与 Promius Pharma LLC 相关的临床结果

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0 项与 Promius Pharma LLC 相关的专利（医药）

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项与 Promius Pharma LLC 相关的文献（医药）

2020-12-01·The journal of headache and pain

Comorbid and co-occurring conditions in migraine and associated risk of increasing headache pain intensity and headache frequency: results of the migraine in America symptoms and treatment (MAST) study

Article

作者: Schwedt, Todd J ; Dodick, David W ; Singh, Preeti ; Buse, Dawn C ; Munjal, Sagar ; Bostic, Ryan ; Reed, Michael L ; Fanning, Kristina M ; Lipton, Richard B

Abstract:

Background:

Migraine has many presumed comorbidities which have rarely been compared between samples with and without migraine. Examining the association between headache pain intensity and monthly headache day (MHD) frequency with migraine comorbidities is novel and adds to our understanding of migraine comorbidity.

Methods:

The MAST Study is a prospective, web-based survey that identified US population samples of persons with migraine (using modified International Classification of Headache Disorders-3 beta criteria) and without migraine. Eligible migraine participants averaged ≥1 MHDs over the prior 3 months. Comorbidities “confirmed by a healthcare professional diagnosis” were endorsed by respondents from a list of 21 common cardiovascular, neurologic, psychiatric, sleep, respiratory, dermatologic, pain and medical comorbidities. Multivariable binary logistic regression calculated odds ratios (OR) and 95% confidence intervals for each condition between the two groups adjusting for sociodemographics. Modeling within the migraine cohort assessed rates of conditions as a function of headache pain intensity, MHD frequency, and their combination.

Results:

Analyses included 15,133 people with migraine (73.0% women, 77.7% White, mean age 43 years) and 77,453 controls (46.4% women, 76.8% White, mean age 52 years). People with migraine were significantly (P < 0.001) more likely to report insomnia (OR 3.79 [3.6, 4.0]), depression (OR 3.18 [3.0, 3.3]), anxiety (OR 3.18 [3.0 3.3]), gastric ulcers/GI bleeding (OR 3.11 [2.8, 3.5]), angina (OR 2.64 [2.4, 3.0]) and epilepsy (OR 2.33 [2.0, 2.8]), among other conditions. Increasing headache pain intensity was associated with comorbidities related to inflammation (psoriasis, allergy), psychiatric disorders (depression, anxiety) and sleep conditions (insomnia). Increasing MHD frequency was associated with increased risk for nearly all conditions and most prominent among those with comorbid gastric ulcers/GI bleeding, diabetes, anxiety, depression, insomnia, asthma and allergies/hay fever.

Conclusions:

In regression models controlled for sociodemographic variables, all conditions studied were reported more often by those with migraine. Whether entered into the models separately or together, headache pain intensity and MHD frequency were associated with increased risk for many conditions. Future work is required to understand the causal sequence of relationships (direct causality, reverse causality, shared underlying predisposition), the potential confounding role of healthcare professional consultation and treatment, and potential detection bias.

2019-06-01·Cephalalgia : an international journal of headache2区 · 医学

Predictors of allodynia in persons with migraine: Results from the Migraine in America Symptoms and Treatment (MAST) study

2区 · 医学

Article

作者: Buse, Dawn C ; Dodick, David W ; Reed, Michael L ; Alam, Aftab ; Fanning, Kristina M ; Munjal, Sagar ; Lipton, Richard B ; Schwedt, Todd J

Background:

Cutaneous allodynia is a common clinical feature of migraine that has been associated with reduced efficacy of acute migraine treatments and an increased risk of disease progression.

Objective:

Identify factors associated with allodynia in a sample of adults with migraine.

Methods:

An online survey panel was used to identify adults with migraine who averaged at least 1 monthly headache day over the previous 3 months. Data on sociodemographics, headache frequency, headache pain intensity, migraine symptom severity, medication use, depression and anxiety, and cutaneous allodynia (via the Allodynia Symptom Checklist) were obtained. Binary logistic modeling predicted the presence of allodynia. Odds ratios and 95% confidence intervals (CI) were calculated.

Results:

In total, 15,133 individuals with migraine met the eligibility criteria. Mean age was 43.1 years, 73.0% were female, and 81.0% were Caucasian. Allodynia was present in 39.9%. The fully adjusted model, controlling for sociodemographics and headache features, demonstrated that allodynia was significantly associated with a higher migraine symptom severity score (odds ratio 1.17, confidence interval 1.15, 1.19) and more severe pain intensity (odds ratio 1.11, confidence interval 1.08, 1.14); probable depression and/or anxiety (odds ratio 1.83, confidence interval 1.67, 2.00); and overuse of acute medication (odds ratio 1.23, confidence interval 1.09, 1.38). A higher number of monthly headache days increased the likelihood of allodynia, but the effect was attenuated in the fully adjusted model.

Conclusion:

In a representative sample of US adults with migraine, there were significant associations between allodynia and headache frequency and intensity, anxiety and/or depression, symptom severity, and acute medication overuse.

2019-04-01·CNS drugs2区 · 医学

DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment

2区 · 医学

Article

作者: Lipton, Richard B ; Brand-Schieber, Elimor ; Rapoport, Alan M ; Munjal, Sagar

BACKGROUND:

The commercial formulation of sumatriptan nasal spray is an effective option for migraine patients requiring or preferring a non-oral route of drug administration, but its utility is limited by poor absorption and tolerability issues. DFN-02, a new formulation of sumatriptan 10 mg nasal spray, is co-formulated with a permeation enhancer that gives it pharmacokinetics comparable to subcutaneous sumatriptan. As reported previously, DFN-02 was significantly better than placebo on multiple efficacy endpoints at 2 h postdose, including pain freedom, absence of the most bothersome symptom, and pain relief, and its safety and tolerability profiles were excellent.

OBJECTIVE:

The objective of this study was to assess the efficacy of acute treatment of migraine with DFN-02, including its effect on migraine-related functional disability and patient satisfaction with treatment.

METHODS:

This was a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of DFN-02 in adults with episodic migraine. Functional disability and subject satisfaction with treatment were prespecified endpoints, assessed in real-time by subjects, using an electronic diary.

RESULTS:

In total, 107 subjects were randomized. DFN-02 was significantly superior to placebo for the reduction in functional disability score from predose level at 2 h after treatment (- 1.2 vs. - 0.6, p < 0.001). Subjects treated with DFN-02 were also more likely to be satisfied or very satisfied than subjects treated with placebo at 2 h postdose (70.0% vs. 44.2%, p = 0.027). Using the Patient Perception of Migraine Questionnaire-Revised at 24 h postdose, DFN-02 mean scores were significantly superior to placebo for the subscales of efficacy (65.2 vs. 42.5, p = 0.016) and function (68.9 vs. 42.1, p = 0.001), and for total score (71.0 vs. 56.6, p = 0.016); global medication effectiveness (p = 0.027); and overall satisfaction (p = 0.019). Placebo was significantly better than DFN-02 on the tolerability subscale (94.8 vs. 88.5, p = 0.026). At 24 h postdose, subjects reported significantly higher satisfaction with DFN-02 compared with satisfaction reported pre-randomization regarding their usual migraine medication (p = 0.012).

CONCLUSION:

DFN-02 was superior to placebo for the relief of migraine-related functional disability, and provided greater satisfaction than placebo or subjects' usual acute treatment.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT02856802.

项与 Promius Pharma LLC 相关的新闻（医药）

2022-12-20

·Business Wire

Papulopustular Rosacea Drug Pipeline Landscape Report 2022 Featuring Key Players - Timber Pharmaceuticals, Dermata Therapeutics, CAGE Bio, Promius Pharma, Alfasigma, BioMimetix - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Papulopustular Rosacea - Pipeline Insight, 2022" drug pipelines has been added to ResearchAndMarkets.com's offering. This "Papulopustular Rosacea- Pipeline Insight, 2022" report provides comprehensive insights about 20+ companies and 20+ pipeline drugs in Papulopustular Rosacea pipeline landscape. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Papulopustular Rosacea pipeline landscape is provided which includes the disease overview and Papulopustular Rosacea treatment guidelines. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The assessment part of the report embraces, in depth Papulopustular Rosacea commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Papulopustular Rosacea collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Papulopustular Rosacea R&D. The therapies under development are focused on novel approaches to treat/improve Papulopustular Rosacea. Papulopustular Rosacea Emerging Drugs Chapters This segment of the Papulopustular Rosacea report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Papulopustular Rosacea Emerging Drugs DMT310: Dermata Therapeutics DMT310 is the lead product candidate, developed from Spongilla platform technology. The unique product candidate is derived from a natural source of Spongilla lacustris, which contains multiple active components to treat a variety of inflammatory skin diseases with once weekly applications. It is currently under development for the treatment of moderate to severe acne, mild to moderate psoriasis and moderate to severe papulopustular rosacea. It contains a unique freshwater sponge that is harvested from a select region of the world, under specific environmental conditions to ensure the sponge retains its distinctive anti-inflammatory, anti-microbial and mechanical properties. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria) and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which is believed to play a significant role in the treatment of inflammatory skin diseases, such as acne. BPX-04: Timber Pharmaceuticals BPX-04 (minocycline), is a novel topical gel formulation of fully solubilized minocycline for the treatment of moderate-to-severe papulopustular rosacea. The product has demonstrated safety and efficacy in a randomized, double-blind, vehicle-controlled Phase 2b clinical trial which enrolled 206 subjects with moderate-to-severe papulopustular rosacea. In addition to meeting the primary and secondary endpoints of the trial, BPX-04 demonstrated a statistically significant reduction in the number of facial inflammatory lesions at all-time points (weeks 4, 8 and 12). Papulopustular Rosacea: Therapeutic Assessment This segment of the report provides insights about the different Papulopustular Rosacea drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Papulopustular Rosacea There are approx. 20+ key companies which are developing the therapies for Papulopustular Rosacea. The companies which have their Papulopustular Rosacea drug candidates in the most advanced stage, i.e. Phase II, Timber Pharmaceuticals. Papulopustular Rosacea: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Papulopustular Rosacea therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Papulopustular Rosacea drugs. Papulopustular Rosacea Report Insights Papulopustular Rosacea Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Papulopustular Rosacea Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Timber Pharmaceuticals Dermata Therapeutics CAGE Bio Promius Pharma Alfasigma BioMimetix Key Products DMT310 BPX-04 CGB-400 DFD-29 Rifaximin BMX-010 For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/xy8lbe

临床2期临床结果

2019-01-28

·BioPortfolio

Dr. Reddy's, Promius' migraine therapy gains FDA nod

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