Social anxiety disorder

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
Mental Health, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Columbia University, Depression, Central nervous system, Paroxetine, Sertraline, Liebowitz social anxiety scale, Anxiety, New Drug Application, Fear, Fasedienol, Clinical trial, NDA, SAD, Headache, CNS, New York State Psychiatric Institute, Trial of the century, Hamilton Anxiety Rating Scale, PRN, DSM-IV codes, Disorder, Patient, LSAS, Anxiety disorder, Social anxiety disorder, Principal, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Nursing, Ajda

“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.

ANANDA Scientific Announces First Patient Enrolled in FDA-approved Clinical Trial Evaluating a Potential New Treatment for Social Anxiety Disorder (SAD)

Retrieved on: 
Tuesday, March 28, 2023
Research, Mental Health, FDA, Cannabis, Clinical Trials, Biotechnology, Pharmaceutical, Health, Natural Resources, Science, National Center for Complementary and Integrative Health, Alternative medicine, NCCIH, NYU, Clinical trial, Neuroimaging, New York University Grossman School of Medicine, SAD, Multimedia, Doctor of Philosophy, Prolonged exposure therapy, Assistant, TSST, Trier social stress test, Master of Science, Psychiatry, Social anxiety disorder, IND, NIH, Cannabidiol, Pharmaceutical industry, Anxiety, MD, CBD

ANANDA Scientific Inc. , a research focused bio-pharmaceutical company today announced that the first subject has been enrolled in the clinical trial with an FDA-approved IND evaluating Nantheia™ A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary Liquid Structure™ delivery technology as a potential treatment for Social Anxiety Disorder (SAD).

Key Points: 
  • ANANDA Scientific Inc. , a research focused bio-pharmaceutical company today announced that the first subject has been enrolled in the clinical trial with an FDA-approved IND evaluating Nantheia™ A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDA’s proprietary Liquid Structure™ delivery technology as a potential treatment for Social Anxiety Disorder (SAD).
  • The National Center for Complimentary and Integrative Health (NCCIH-a division of the NIH) is providing funding for this trial which is being conducted at the NYU Grossman School of Medicine .
  • ( Clinical Trials.gov Identifier: NCT05571592 )
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20230328005224/en/
    Pictured above are Principal Investigators Naomi Simon MD, MSc, Esther Blessing MD, PhD, and Ananda Scientific CEO Sohail Zaidi.

Clinical Trial of Arcade Therapeutics' Flagship Therapeutic Mobile Game, StarStarter Rx, Shows Robust Reductions in Social Anxiety in Adults

Retrieved on: 
Thursday, March 23, 2023
Arcade, Liebowitz social anxiety scale, Anxiety, Policy, COVID-19, SAD, Document Number Nine, Document, DSM-IV codes, Food and Drug Administration Amendments Act of 2007, Patient, Beck Depression Inventory, LSAS, Social anxiety disorder, Generalized anxiety disorder, Beck, FDA, Therapy, Social anxiety, Food, Safety, Nursing, Pharmaceutical industry

Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.

Key Points: 
  • Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.
  • "We are thrilled by these promising results as we continue down the path toward FDA submission of StarStarter Rx as the first game-based treatment for Social Anxiety Disorder."
  • StarStarter Rx is available with the Arcade Connect DTx deployment platform, which includes integration features, clinical assessments, and HIPAA-consent management.
  • StarStarter Rx is not intended for use as a standalone therapy and does not represent a substitution for your medication.

Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder

Retrieved on: 
Wednesday, March 22, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Central nervous system, Depression, Anxiety, Safety, Overalls, COVID-19, Aes, Fear, Liebowitz social anxiety scale, SAD, Headache, CNS, Selective serotonin reuptake inhibitor, Patient, LSAS, Social anxiety disorder, SNRI, PH94B, FDA, Wireless ambulatory ECG, Pharmaceutical industry

Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives.

Key Points: 
  • Secondary endpoints in the study included evaluation of the change from baseline on the Liebowitz Social Anxiety Scale (LSAS), which measures SAD patients’ response to anxiety-provoking social and performance situations experienced in their daily lives.
  • The safety and exploratory LSAS results of this Phase 3 open label study build on the safety and LSAS efficacy results from a previous randomized, double-blind, placebo-controlled Phase 2 study of fasedienol in a real-world setting.
  • All prior registration studies for these medications were positive, and all studies used the LSAS as the primary efficacy endpoint.
  • At the time of study closure, study participants had a mean trial exposure of 120 days and a maximum exposure of 320 days.

Bionomics Reports Promising Full Results Analysis from PREVAIL Phase 2 Study of BNC210 Social Anxiety Disorder (SAD)

Retrieved on: 
Thursday, March 9, 2023
Subjective units of distress scale, BNO, Clutch (eggs), Anxiety, Patient, FDA, SUDS, Central nervous system, Social anxiety disorder, Benzodiazepine, SAD, STAI, Data, Doctor of Philosophy, CNS, MPH, BNC210, Safety, Pharmaceutical industry, MD, Bionomics, Webcast

While PREVAIL did not meet its primary endpoint, the December 2022 topline data readout revealed encouraging trends in the prespecified endpoints that focused on individual phases of the public speaking task.

Key Points: 
  • While PREVAIL did not meet its primary endpoint, the December 2022 topline data readout revealed encouraging trends in the prespecified endpoints that focused on individual phases of the public speaking task.
  • These results supported a post-hoc in-depth analysis of the full dataset to better understand the true potential of the drug and guide late-stage trial design.
  • Converging trends favouring BNC210 were also observed in the State-Trait Anxiety Inventory (STAI).
  • In addition to the favourable efficacy, the overall safety profile of BNC210 was found to be consistent with a non-sedating anxiolytic.

Antidote Health Teams Up with Charles Antetokounmpo Family Foundation to Provide Mental Health Services, ‘Leave No One Behind’

Retrieved on: 
Thursday, March 9, 2023
Basketball, Philanthropy, Mental Health, Health, Sports, Telemedicine, Virtual Medicine, Foundation, National Alliance, Physician, Generalized anxiety disorder, PTSD, Social anxiety disorder, Post-traumatic stress disorder, National Alliance on Mental Illness, GAD, Panic attack, Obsessive–compulsive disorder, CAFF, Organization, Panic disorder, OCD, Mental disorder, Nursing, Antidote

“I believe that by investing in others, we unlock their true potential, regardless of their origin, race, color or faith.

Key Points: 
  • “I believe that by investing in others, we unlock their true potential, regardless of their origin, race, color or faith.
  • That’s why I’m delighted that CAFF and Antidote Health have come together to provide mental health care services to those in-need.
  • According to the National Alliance on Mental Illness, 1 in 5 adults in the United States experience mental illness each year.
  • Under the terms of the “Leave No One Behind” program, eligible Wisconsin residents will receive free mental health care treatment conducted via teleconference with a board-certified physician.

Bionomics’ Half-Year Report

Retrieved on: 
Thursday, February 23, 2023
MSD, Safety, American depositary receipt, Post-traumatic stress disorder, SUDS, BNC210, Deficit spending, Subjective units of distress scale, Merck, Social anxiety disorder, Bionomics, ASX, PAMS, Partnership, SAD, Merck & Co., United Kingdom, Research, Patient, PTSD, MDMA, CNS, Non-executive director, Public, BNO, ADS, Data, Pharmaceutical industry

ADELAIDE, Australia, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, NASDAQ: BNOX), today announced its FY2023 report for the half-year ended 31 December 2022.

Key Points: 
  • ADELAIDE, Australia, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, NASDAQ: BNOX), today announced its FY2023 report for the half-year ended 31 December 2022.
  • The Company recently completed its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of Social Anxiety Disorder (SAD).
  • The PREVAIL Study completed recruitment, and topline data were reported on 19 December 2022.
  • The Company is continuing its analysis of the PREVAIL dataset and is assessing the next steps for the development of BNC210 in SAD.

Vistagen Provides Corporate Update and Reports Fiscal 2023 Third Quarter Financial Results

Retrieved on: 
Tuesday, February 7, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, New Drug Application, PIN, Hot, PALISADE, DSM-IV codes, Probenecid, Safety, PH94B, Acquisition, NMDA, SAD, Patient, PH10, Depression, Food, LSAS, CNS, Fear, G&A, Anxiety, Social anxiety disorder, MDD, Liebowitz social anxiety scale, Migraine, FDA, Research, Calendar, Central nervous system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Cognition, Fast Track, FTD, R, IND, Pharmaceutical industry, Medical device, Cryptocurrency, Broadcasting, Ajda

“Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Should Vistagen resume PALISADE-2, the proposed amendments are intended to address various methodological issues believed to have contributed to the unexpected results of PALISADE-1.
  • Vistagen anticipates reporting topline results from this exploratory Phase 2A AjDA trial by the end of the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its third quarter fiscal year 2023 ended December 31, 2022 and provide a corporate update.

Vistagen Announces Closing of Pherin Pharmaceuticals Acquisition

Retrieved on: 
Thursday, February 2, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, Additive effect, DSM-IV codes, Drug development, PH94B, Acquisition, SAD, PH10, Depression, Mixed anxiety–depressive disorder, CNS, Anxiety, Social anxiety disorder, MDD, Ajda, Migraine, Central nervous system, Cognition, Hot, Pharmaceutical industry, Pherine

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).
  • Vistagen’s acquisition of Pherin eliminates all future royalty payment obligations related to its five pherine nasal spray drug candidates.
  • “This acquisition is another important step in our plan to develop and commercialize PH94B and PH10 as innovative treatments for millions of individuals struggling with anxiety and depression disorders,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • This acquisition significantly improves the potential future commercial profile of each drug candidate.”
    Additional details regarding the closing of Vistagen’ acquisition of Pherin can be found in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission today and available in the Investors section of Vistagen’s website.

Quarterly Activities and Cashflow Report

Retrieved on: 
Monday, January 30, 2023
Australian Government, Credit, Corporate governance, ASX, PTSD, Bionomics, Non-executive director, Quarter, ADS, BNC210, Evercore, Credit Suisse, Subjective units of distress scale, Executive, Research, Public, CNS, Mass meeting, Evaluation, Conference, SUDS, ACDT, Annual general meeting, BNO, Fireside chats, Social anxiety disorder, Proportionality (law), United Kingdom, Contract research organization, Fireside, Allosteric regulation, KOL, Data, Social anxiety, American College, Safety, GABAA receptor negative allosteric modulator, Central nervous system, Patient, SAD, Annual report, Pharmaceutical industry, Renewable energy, Health insurance, Animal, Management, MD

Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.

Key Points: 
  • Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.
  • On 25 October 2022, Bionomics released the Quarterly Activities Report for the quarter ending September 2022.
  • Finally, with the additional financing activities during the quarter, the Company has sufficient cash runway to support its ongoing activities and upcoming milestones with runway to at least mid-2024.
  • A copy of the full release, including a copy of the ASX Appendix 4C Cashflow Report can be found on the Company's website.