Antidepressants

Harmony Biosciences Presents Efficacy And Safety Analyses For WAKIX® (pitolisant) At Virtual SLEEP 2020

Retrieved on: 
Friday, August 28, 2020

Harmony is presenting a total of four posters in the Virtual SLEEP 2020 Exhibit Hall, three of which are post-hoc analyses of the efficacy and safety data from the clinical development program for WAKIX.

Key Points: 
  • Harmony is presenting a total of four posters in the Virtual SLEEP 2020 Exhibit Hall, three of which are post-hoc analyses of the efficacy and safety data from the clinical development program for WAKIX.
  • "We are pleased to participate in this year's SLEEP 2020 virtual meeting and share clinically relevant data supporting WAKIX with healthcare professionals and the sleep medicine community," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D.
  • "The results presented from post-hoc analyses of the clinical data help further characterize the efficacy and safety profile of WAKIX to assist healthcare professionals in making treatment decisions for their patients living with narcolepsy."
  • WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.

Champignon to Begin Offering Esketamine Treatment for Adults With Major Depressive Disorder at the Canadian Rapid Treatment Centre of Excellence

Retrieved on: 
Thursday, August 27, 2020

VANCOUVER, British Columbia, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Champignon Brands Inc. (CSE: SHRM) (the Company or Champignon) is expanding its rapid-onset treatment service for major depressive disorder (MDD).

Key Points: 
  • VANCOUVER, British Columbia, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Champignon Brands Inc. (CSE: SHRM) (the Company or Champignon) is expanding its rapid-onset treatment service for major depressive disorder (MDD).
  • Champignon will offer esketamine for the treatment of adults with MDD at its flagship clinic starting in September 2020.
  • In May 2020, Health Canada approved esketamine for the treatment of MDD.
  • Champignons clinic, the Canadian Rapid Treatment Centre of Excellence (the CRTCE) is Canada's first multidisciplinary community clinic offering rapid-onset treatments for depression and is expected to be the first of its kind to provide this novel treatment for depression in Canada.

Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 10, 2020

Depression: Axsome remains on track to submit a New Drug Application (NDA) to the FDA for AXS-05 for the treatment of MDD in the fourth quarter of 2020.

Key Points: 
  • Depression: Axsome remains on track to submit a New Drug Application (NDA) to the FDA for AXS-05 for the treatment of MDD in the fourth quarter of 2020.
  • Axsome remains on track to initiate a second Phase 3 trial of AXS-05 in AD agitation in the second half of 2020.
  • Cash: At June 30, 2020, Axsome had $190.7 million of cash compared to $197.3 million of cash at March 31, 2020.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss second quarter 2020 financial results as well as to provide a corporate update.

Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program

Retrieved on: 
Monday, August 10, 2020

Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.

Key Points: 
  • Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.
  • Axsome remains on track to achieve the required number of patients treated for one year in the fourth quarter.
  • The trial endpoints will include the change from baseline in the Montgomery-sberg Depression Rating Scale (MADRS) total score, clinical response, and remission.
  • MERIT Trial Axsome is conducting the MERIT trial, a Phase 2, double-blind, placebo-controlled, randomized withdrawal study of AXS-05 in patients with TRD.

Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy

Retrieved on: 
Wednesday, August 5, 2020

Axsome previously received Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy.

Key Points: 
  • Axsome previously received Orphan Drug Designation from the FDA for AXS-12 for the treatment of narcolepsy.
  • The Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in narcolepsy was supported by the positive results from the Phase 2 CONCERT study, a randomized, double-blind, placebo-controlled, crossover, multicenter U.S. trial.
  • Axsome has now received three FDA Breakthrough Therapy designations, including designations for AXS-05 in major depressive disorder and for AXS-05 in Alzheimers disease agitation.
  • AXS-12 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and Orphan Drug Designation for the treatment of narcolepsy.

Chiasma Announces 48-Week Safety and Efficacy Data from the Open-Label Extension Study of its CHIASMA OPTIMAL Phase 3 Trial Evaluating MYCAPSSA® in Patients with Acromegaly

Retrieved on: 
Monday, July 27, 2020

The OLE study, which is still ongoing, is examining the longer-term safety and efficacy of MYCAPSSA in patients who participated in our Phase 3 CHIASMA OPTIMAL clinical trial.

Key Points: 
  • The OLE study, which is still ongoing, is examining the longer-term safety and efficacy of MYCAPSSA in patients who participated in our Phase 3 CHIASMA OPTIMAL clinical trial.
  • 90% of patients enrolled into the OLE that were treated with MYCAPSSA during the DPC phase of the study (n=20) completed the 48-week OLE period.
  • The safety profile observed during OLE was generally consistent with the safety of MYCAPSSA noted in the 36-week CHIASMA OPTIMAL trial with no new patterns noted with the increased duration of exposure.
  • Patients taking proton pump inhibitors, H2-receptor antagonists, or antacids concomitantly with MYCAPSSA may require increased dosages of MYCAPSSA.

ACADIA Pharmaceuticals Announces Top-line Results from the Phase 3 CLARITY Study Evaluating Pimavanserin for the Adjunctive Treatment of Major Depressive Disorder

Retrieved on: 
Monday, July 20, 2020

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from its 298 patient Phase 3 CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder (MDD).

Key Points: 
  • ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from its 298 patient Phase 3 CLARITY study which combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder (MDD).
  • All of us at ACADIA thank the patients, their families and the investigators who participated in the Phase 3 CLARITY study.
  • Phase 3 CLARITY Study Results:
    Statistical significance not achieved on the primary endpoint: HAMD-17 (p=0.296).
  • ACADIA previously announced plans to combine its CLARITY-2 and CLARITY-3 Phase 3 studies evaluating pimavanserin for the adjunctive treatment of MDD with a pre-specified statistical analysis plan.

Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder

Retrieved on: 
Monday, July 13, 2020

Axsome received Breakthrough Therapy Designation from the FDA for AXS-05 for the treatment of MDD in March 2019.

Key Points: 
  • Axsome received Breakthrough Therapy Designation from the FDA for AXS-05 for the treatment of MDD in March 2019.
  • Axsome is pleased with the outcome of our recent pre-NDA meeting with the FDA, which confirmed the studies and data to be presented in our planned NDA submission of AXS-05 in major depressive disorder, said Herriot Tabuteau, MD, Chief Executive Officer of Axsome.
  • If approved, AXS-05 has the potential to be the first oral, NMDA receptor antagonist for the treatment of depression.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as treatment for smoking cessation.

OWP Pharmaceuticals Announces Patent Application for the First-Ever Powder for Oral Liquid Formulation of Duloxetine Hydrochloride for the Treatment of Major Depressive and Generalized Anxiety Disorder

Retrieved on: 
Wednesday, July 8, 2020

Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) and the delayed-release capsules, for oral use, were first approved in the U.S. in 2004.

Key Points: 
  • Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) and the delayed-release capsules, for oral use, were first approved in the U.S. in 2004.
  • In major depressive and generalized anxiety disorders, duloxetine hydrochloride is indicated for treatment in adults.
  • If approved, this would represent the first-ever powder for oral liquid formulation available for duloxetine hydrochloride.
  • Healthcare providers may also find that in this form, the dosage may be easier to titrate and adjust.

Aldeyra Therapeutics Announces New Drug Application (NDA) Development Plans for Dry Eye Disease

Retrieved on: 
Tuesday, July 7, 2020

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease.
  • In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020.
  • Reproxalap is a novel investigational small-molecule immune-modulating covalent inhibitor of RASP in development as a topically administered ophthalmic solution for dry eye disease and allergic conjunctivitis.
  • 2016, 41(9):1143-9; Reproxalap preclinical and Phase 2a in dry eye disease clinical trial results on file.