Hamilton Anxiety Rating Scale

MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder

Retrieved on: 
Thursday, December 14, 2023
Health, FDA, Neurology, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Medicine, NEO, Hamilton Anxiety Rating Scale, Week, MindMed, GAD, Pharmaceutical industry, Vaccine

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD).

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced positive topline results from its Phase 2b clinical trial of MM-120 (lysergide d-tartrate) in generalized anxiety disorder (GAD).
  • The Company expects that results of this study will support the advancement of MM-120 into Phase 3 clinical development for GAD.
  • MindMed management will host a conference call at 8:30 AM EST today to discuss the results of MM-120 in GAD.
  • The webcast can be accessed live here on the News & Events page in the Investors section of the MindMed website, https://mindmed.co/ .

Bionomics Completes Last Patient Last Visit in the Phase 2b ATTUNE Study for Post-Traumatic Stress Disorder (PTSD) and Confirms Expected 2023 Milestones with its Lead Asset BNC210

Retrieved on: 
Wednesday, August 23, 2023
Clinician Administered PTSD Scale, ISI, Central nervous system, Depression, BNC210, Official List, FOR, Montgomery–Åsberg Depression Rating Scale, Anxiety, SDS, Sleep, BNO, SAD, Australian Securities Exchange, DSM-IV codes, Hamilton Anxiety Rating Scale, Phase 3, Patient, Insomnia, Social anxiety disorder, United Kingdom, PGI, CGI, DSM-5, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Bionomics, PTSD

“I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study.

Key Points: 
  • “I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study.
  • The EoPh2 meeting to discuss advancing BNC210 into Phase 3 development as an acute treatment for SAD has been scheduled for mid-September 2023.
  • Additionally, Bionomics is scheduled to delist from the Official List of the Australian Securities Exchange on 28 August 2023.
  • The Company will remain an Australian incorporated company and will maintain its listing of ADSs on Nasdaq under the trading symbol ‘BNOX’.

Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder

Retrieved on: 
Wednesday, April 26, 2023
Mental Health, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, GAD, Commercialization, Senior, Sunovion, Ulotaront, Week, Schizophrenia, Anxiety, TAAR1, Multimedia, Appetite, Trial of the century, Sleep, Hamilton Anxiety Rating Scale, Anxiety disorder, DSM-IV codes, MDD, Patient, Mental health, Safety, Pharmaceutical industry, Nursing

Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, for the treatment of generalized anxiety disorder (GAD).

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, for the treatment of generalized anxiety disorder (GAD).
  • In addition to GAD, ulotaront is being investigated in late-stage clinical studies for the treatment of schizophrenia and for the adjunctive treatment of major depressive disorder (MDD).
  • “Preliminary data from preclinical and clinical studies of ulotaront suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD.
  • The primary endpoint is reduced anxiety symptoms, as measured by a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score, compared to placebo at Week 8.

FDA Provides Positive Feedback to Vistagen Regarding Use of the Liebowitz Social Anxiety Scale (LSAS) as an Endpoint in Phase 3 Development of Fasedienol (PH94B) for Treatment of Social Anxiety Disorder

Retrieved on: 
Thursday, March 30, 2023
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“With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “With positive feedback from the FDA, we’re focused on advancing a clinical study design with the Liebowitz Social Anxiety Scale as the primary endpoint to study the real-world effects of fasedienol over time,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • “This is an important step forward, especially as SAD is becoming even more prevalent in a post-COVID world.
  • Dr. Liebowitz was among the clinical investigators involved in the registrational efficacy trials for all of these drugs, and all of such registrational trials were positive.
  • Results of the AjDA study may provide support for an as-needed (PRN) fasedienol dosing approach over time as the preferred mode of treatment.

Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety

Retrieved on: 
Tuesday, January 10, 2023
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Principal, New York State Psychiatric Institute, Mental health, Depression, CNS, Anxiety, Safety, Ajda, Health, Hamilton Anxiety Rating Scale, Columbia University, Central nervous system, Prevalence, PH94B, Data analysis, Anxiety disorder, Pharmaceutical industry

The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.

Key Points: 
  • The exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults.
  • The primary endpoint is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of treatment with PH94B or placebo.
  • This is a major milestone for our team,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • Vistagen is dedicated to developing treatments to address the escalating mental health crisis.

VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder

Retrieved on: 
Thursday, October 14, 2021
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SOUTH SAN FRANCISCO, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression, and other central nervous system (CNS) disorders, today announced the initiation of a Phase 2A clinical trial to evaluate the efficacy, safety and tolerability of PH94B as a potential treatment of anxiety in adults with Adjustment Disorder with Anxiety (AjDA). In parallel with advancing its ongoing PALISADE Phase 3 clinical program for PH94B in the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD), the Company plans to explore PH94B’s potential in additional anxiety disorders through a series of small Phase 2A trials, the first of which is in AjDA. PH94B is an investigational pherine nasal spray with a unique potential mechanism of action designed to achieve rapid-onset anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects and safety concerns.

Key Points: 
  • The exploratory Phase 2A clinical trial of PH94B in AjDA is a randomized, double-blind, placebo-controlled study with an enrollment target of approximately 40 adults at clinical sites in the Boston and New York City metro areas.
  • As we continue to advance ongoing Phase 3 clinical development of PH94B in our PALISADE Phase 3 Program in Social Anxiety Disorder, we are excited to launch our Phase 2A clinical program to explore PH94Bs potential in multiple additional anxiety disorders with unmet need, said Shawn Singh, Chief Executive Officer of VistaGen.
  • Expanding on our ongoing efforts to address the alarming prevalence of Social Anxiety Disorder, the initiation of this exploratory Phase 2A study in Adjustment Disorder with Anxiety is an exciting next step toward our goal.
  • In addition, VistaGens exploratory Phase 2A clinical program for PH94B in additional anxiety disorders is now underway with the recent initiation of its Phase 2A clinical trial in AjDA.

American BriVision Announces Issuance of a Full Clinical Study Report (CSR) for ABV-1504 for Major Depressive Disorder Phase II Study

Retrieved on: 
Thursday, November 14, 2019
Clinical research, Clinical psychology, Medicine, Hamilton Rating Scale for Depression, Health, Placebo, Hamilton Anxiety Rating Scale

In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group.

Key Points: 
  • In the per protocol population, the high-dose cohort had a 13.4-point reduction in MADRS as compared to an 8.6-point reduction in the placebo group.
  • A significant group difference in net change in HAM-D-17 and HAM-A (Hamilton Anxiety Rating Scale) at week 2 was also found.
  • Post-hoc, pair-wise comparisons demonstrated a significant difference between high-dose group and placebo group in HAM-D-17 (High dose -7.90 vs.
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.