Hyperhidrosis

Brickell Biotech Expands Leadership Team, Appointing Dr. Monica Luchi as Chief Medical Officer

Retrieved on: 
Wednesday, September 1, 2021
College of Medicine, DYRK1A, Innovation and Entrepreneurship Group, University, Medicine, George Washington University, Therapy, Strategic planning, U.S. Securities and Exchange Commission, Acquisition, GLOBE, SEC, Leadership, Drug, Rheumatology, Biology, Research, Nasdaq, Private Securities Litigation Reform Act, BBI, Hyperhidrosis, Humanitarian use licenses, Clinical, Stanford University, Time, Intellectual property, NDA, Autoimmunity, Outline of health sciences, Policy, Clinical trial, MBA, University of Maryland, College Park, Board, Degenerative disease, Immunology, Patient, Novartis, Trustee, M.B.A, COVID-19, Director, Dermatology, Drug development, MD, Pharmaceutical industry

In this new role, Dr. Luchi will oversee the Companys clinical development strategy and medical affairs functions.

Key Points: 
  • In this new role, Dr. Luchi will oversee the Companys clinical development strategy and medical affairs functions.
  • We are delighted to have Dr. Luchi join our team at this transformative point in our Companys history.
  • She was most recently working as the interim Chief Medical Officer and a Clinical Development consultant for the Bracken Group.
  • The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

Brickell Biotech Announces Final Patient Completed Second U.S. Phase 3 Pivotal Clinical Study of Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidrosis

Retrieved on: 
Monday, August 16, 2021
Time, II, Intellectual property, Blood, Population, Clinical trial, University of Florida, Anticholinergic, Sweatpants, Exocrine gland, Company, Private Securities Litigation Reform Act, Safety, University, COVID-19, GLOBE, Research, Nervous system, Hyperhidrosis, BBI, SEC, NDA, U.S. Securities and Exchange Commission, Cardigan, Patient, Leadership, Development, Humanitarian use licenses, Nasdaq, Therapy, Acetylcholine, GSP, Prevalence, Graduate, Pharmaceutical industry

BOULDER, Colo., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that the final patient has completed the Phase 3 pivotal Cardigan II study, which is evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis. The Company expects to announce topline results for the U.S. Phase 3 pivotal Cardigan I and Cardigan II studies concurrently in the fourth quarter of 2021. Pending the outcome of these studies, the Company expects to submit a New Drug Application (NDA) for sofpironium bromide gel, 15% to the U.S. FDA in mid-2022.

Key Points: 
  • Were excited to announce that all patients have now completed their final visits in the Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis.
  • Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II.
  • Each study has enrolled approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis.
  • The studies are multicenter, randomized, double-blinded, vehicle (placebo)-controlled studies evaluating the efficacy and safety of topically applied sofpironium bromide gel, 15%.

Brickell Biotech Reports Second Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 12, 2021
Income, Time, Trial of the century, II, Intellectual property, Blood, Awareness, Population, Clinical trial, University of Florida, Anticholinergic, Sweatpants, Research, Exocrine gland, Company, Private Securities Litigation Reform Act, University, COVID-19, GLOBE, Forgiveness, Hyperhidrosis, BBI, SEC, Pharmacokinetics, NDA, Nervous system, FDA, U.S. Securities and Exchange Commission, Conference, Cardigan, Patient, Leadership, Perspiration, Humanitarian use licenses, PK, Nasdaq, Safety, Therapy, Acetylcholine, Prevalence, Graduate, Pharmaceutical industry

BOULDER, Colo., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell” or the “Company”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced financial results for the second quarter ended June 30, 2021 and provided a corporate update.

Key Points: 
  • Research and development expenses were $8.8million for the second quarter of 2021, compared to $2.7million for the second quarter of 2020.
  • General and administrative expenses were $2.9million for the second quarter of 2021, compared to $3.0million for the second quarter of 2020.
  • Total other income, net was $0.4million for the second quarter of 2021, compared to $7thousand for the second quarter of 2020.
  • Brickells net loss was $11.1million for the second quarter of 2021 compared to $5.1million for the second quarter of 2020.

Brickell Biotech to Participate at William Blair’s Biotech Focus Conference 2021

Retrieved on: 
Tuesday, July 6, 2021
Hyperhidrosis, Thoracic surgery, Medical specialties, Health care, Life sciences

BOULDER, Colo., July 06, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (Brickell) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that its management team will participate in one-on-one investor meetings at the upcoming William Blair Biotech Focus Conference 2021, taking place virtually July 14 - 15.

Key Points: 
  • BOULDER, Colo., July 06, 2021 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (Brickell) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that its management team will participate in one-on-one investor meetings at the upcoming William Blair Biotech Focus Conference 2021, taking place virtually July 14 - 15.
  • Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development of innovative and differentiated prescription therapeutics for debilitating skin diseases with a focus on its lead asset sofpironium bromide for the treatment of hyperhidrosis.
  • Brickells strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative and differentiated pharmaceutical products that Brickell believes can be successful in the marketplace and transform lives by solving currently unmet patient needs.
  • For more information, visit https://www.brickellbio.com .

Dermadry's Anti Sweat Device Secures the Seal of Approval from the American Podiatric Medical Association

Retrieved on: 
Wednesday, June 30, 2021
Branches of biology, Medicine, Anatomy, Hyperhidrosis, Thoracic surgery, American Podiatric Medical Association, Podiatry, Perspiration, Non-contact thermography, Food and Drug Administration

Which is why Dermadry is proud to announce that they have received the Seal of Approval from the American Podiatric Medical Association (APMA) for Dermadry Total.

Key Points: 
  • Which is why Dermadry is proud to announce that they have received the Seal of Approval from the American Podiatric Medical Association (APMA) for Dermadry Total.
  • By giving their Seal of Approval to Dermadry Total, APMA recognizes the effectiveness of the product in the treatment of excessive sweating.
  • Dermadry's APMA Seal of Approval arrives just weeks after receiving the CE marking for the Europe market.
  • They manufacture an FDA cleared iontophoresis device that treats hyperhidrosis , a medical condition characterized by excessive sweating.

Brickell Biotech Announces Final Patient Completed in First U.S. Phase 3 Pivotal Clinical Study and Patient Enrollment Completed in Second U.S. Phase 3 Pivotal Clinical Study of Sofpironium Bromide Gel, 15% for the Treatment of Primary Axillary Hyperhidro

Retrieved on: 
Tuesday, June 29, 2021
Health sciences, Health, Clinical research, Design of experiments, Pharmaceutical industry, Hyperhidrosis, Thoracic surgery, Clinical trial, Brickell, Cardigan, Ceredigion

This is truly an exciting time for the Brickell team, as we have now completed enrollment in both of our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15%.

Key Points: 
  • This is truly an exciting time for the Brickell team, as we have now completed enrollment in both of our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15%.
  • We look forward to sharing updates on the progress of the Phase 3 pivotal clinical studies over the coming months.
  • Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II.
  • Each study has enrolled approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis.

Brickell Biotech Announces Initiation of a Phase 1 Study of Sofpironium Bromide Gel in Primary Palmoplantar Hyperhidrosis Patients by its Development Partner, Kaken Pharmaceutical in Japan

Retrieved on: 
Thursday, June 24, 2021
Clinical research, Health sciences, Health, Medical research, Design of experiments, Hyperhidrosis, Thoracic surgery, Placebo-controlled study, Placebo, Clinical trial

In Japan, 5.33% and 2.79% of the population are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively1.

Key Points: 
  • In Japan, 5.33% and 2.79% of the population are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively1.
  • Depending on the outcome of the Phase 1 study, Kaken and Brickell will determine the next steps, if any, for the development of sofpironium bromide gel in PPH patients in their respective territories.
  • Phase 3 pivotal program for sofpironium bromide gel, 15% which is comprised of two pivotal clinical studies, Cardigan I and Cardigan II.
  • Both randomized, double-blinded, placebo-controlled pivotal studies are evaluating sofpironium bromide gel, 15% vs. placebo (1:1 ratio) in approximately 350 subjects (per study) aged nine and older with primary axillary hyperhidrosis.

Hyperhidrosis Treatment Market Report 2021: Global Industry Analysis, Trends, Market Size, and Forecasts 2020-2026 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 11, 2021
Biotechnology, Pharmaceutical, Health, Hyperhidrosis, Thoracic surgery, Forecasting

The "Hyperhidrosis Treatment Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hyperhidrosis Treatment Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2026" report has been added to ResearchAndMarkets.com's offering.
  • The report predicts the global hyperhidrosis treatment market to grow with a CAGR of 5.00% over the forecast period from 2020-2026.
  • The report on the global hyperhidrosis treatment market provides qualitative and quantitative analysis for the period from 2018 to 2026.
  • The report on hyperhidrosis treatment market is a comprehensive study and presentation of drivers, restraints, opportunities, demand factors, market size, forecasts, and trends in the global hyperhidrosis treatment market over the period of 2018 to 2026.

Salix Will Share RELISTOR® (Methylnaltrexone Bromide) Data Analysis at the 2021 American Society of Clinical Oncology Annual Meeting and 2021 Annual Meeting of the Multinational Association of Supportive Care in Cancer

Retrieved on: 
Thursday, June 3, 2021
Medical specialties, Clinical medicine, Medicine, Opioid antagonists, Morphinans, Substance dependence, Withdrawal syndromes, Sanitation, Methylnaltrexone, Opioid withdrawal, Hyperhidrosis, Abdominal pain

A scientific poster featuring identical data will be presented at the 2021 Annual Meeting of the Multinational Association of Supportive Care in Cancer (MASCC), which will be held virtually June 24-26, 2021.

Key Points: 
  • A scientific poster featuring identical data will be presented at the 2021 Annual Meeting of the Multinational Association of Supportive Care in Cancer (MASCC), which will be held virtually June 24-26, 2021.
  • Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their health care provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR.

Brickell Biotech Reports First Quarter 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, May 13, 2021
Hyperhidrosis, Thoracic surgery, Brickell, Axillary

As a result, we are on track to announce topline data from both studies in the fourth quarter of 2021.

Key Points: 
  • As a result, we are on track to announce topline data from both studies in the fourth quarter of 2021.
  • In this study, sofpironium bromide gel was generally well-tolerated with continued efficacy during 48 weeks in patients with primary axillary hyperhidrosis.
  • ET to discuss the financial results and recent corporate developments.
  • A live webcast of the conference call can be accessed through the \xe2\x80\x9cInvestors\xe2\x80\x9d tab on the Brickell Biotech website at https://www.brickellbio.com .