Social anxiety disorder

Bionomics Announces Intention to Delist from the Australian Securities Exchange (ASX)

Retrieved on: 
Tuesday, July 25, 2023
Central nervous system, BNC210, American depositary receipt, ASX, BNO, SAD, Australian Securities Exchange, Bionomics, CNS, Patient, Social anxiety disorder, PTSD, Acute stress disorder

“Bionomics is approaching several very important value-inflection milestones for our late-stage clinical development program with BNC210, a first and best-in class α7 nicotinic receptor negative allosteric modulator under evaluation in patients with Social Anxiety Disorder (SAD) and Post-Traumatic Stress Syndrome (PTSD), in the coming quarters,” said Spyros Papapetropoulos, M.D.

Key Points: 
  • “Bionomics is approaching several very important value-inflection milestones for our late-stage clinical development program with BNC210, a first and best-in class α7 nicotinic receptor negative allosteric modulator under evaluation in patients with Social Anxiety Disorder (SAD) and Post-Traumatic Stress Syndrome (PTSD), in the coming quarters,” said Spyros Papapetropoulos, M.D.
  • Ph.D., Bionomics’ President and CEO; “As we continue our transformation to a U.S.-focused organization, we would like to deepen our engagement with the broadest range of potential investors and maximize Bionomics’ access to capital and financing opportunities while reducing costs and compliance obligations associated with a dual listing.
  • All information will be made available at https://ir.bionomics.com.au/ .
  • FOR FURTHER INFORMATION PLEASE CONTACT:

Tonix Pharmaceuticals Announces Agreement and Initiation of Enrollment in Phase 2 Trial with the University of Washington to Study TNX-1900 (Potentiated Intranasal Oxytocin) for Social Anxiety Disorder

Retrieved on: 
Monday, July 17, 2023
Tonix Pharmaceuticals, Human, Central nervous system, University, DSM-IV codes, Magnesium, Anxiety, University of Washington, Fear, SAD, University of Bath Department of Psychology, Research, Social cognition, Oxytocin, Assistant professor, Acquisition, Animal, University of Washington School of Social Work, Social anxiety disorder, Behavior, Safety, Nursing, Pharmaceutical industry

Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 with Angela Fang, Ph.D., Assistant Professor, Department of Psychology, University of Washington as the principal investigator.

Key Points: 
  • Tonix entered into an agreement with the University of Washington to examine the potential role of TNX-1900 with Angela Fang, Ph.D., Assistant Professor, Department of Psychology, University of Washington as the principal investigator.
  • “We are excited to collaborate with the University of Washington and Dr. Fang on the development of TNX-1900 for social anxiety disorder,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • These studies have shown that intranasal oxytocin may hold therapeutic promise for psychiatric disorders involving social deficits3-5.
  • The primary objective of the Phase 2 study is to examine the potential role of TNX-1900 in enhancing vicarious extinction learning in SAD, compared to healthy controls.

Public advisory - Certain bottles of JAMP Venlafaxine XR 37.5 mg capsules recalled due to mislabelling that could lead to overdose

Retrieved on: 
Thursday, June 22, 2023
Seizure, Tremor, Allergy, Chills, Anxiety, Blurred vision, Pharmacy, Appetite, Capsule, Pharmacist, Dizziness, DSM-IV codes, Patient, Gastrointestinal bleeding, Panic disorder, Social anxiety disorder, Somnolence, Nausea, Perspiration, Cover My Eyes (Pain and Heaven), XR, Headache, Health Canada, Agitation, Wine, Birth control, Medical device

JAMP Pharma Corporation is recalling mislabelled bottles from lot PTC5140A of Venlafaxine extended release (XR) capsules after one bottle labelled to contain 37.5 mg capsules was found to contain 150 mg capsules.

Key Points: 
  • JAMP Pharma Corporation is recalling mislabelled bottles from lot PTC5140A of Venlafaxine extended release (XR) capsules after one bottle labelled to contain 37.5 mg capsules was found to contain 150 mg capsules.
  • If pharmacists did not recognize the error, they may have repackaged and dispensed pharmacy bottles labelled as containing 37.5 mg capsules, but instead contained 150 mg capsules.
  • Venlafaxine XR 150 mg capsules are caramel in colour with "RVn" printed on the cap and "150" printed on the body.
  • Check the capsules in your pharmacy bottle of JAMP Venlafaxine XR 37.5 mg capsules to make sure it contains 37.5 mg capsules (grey / pink in colour) and not 150 mg capsules (caramel in colour).

Vistagen Presents Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

Retrieved on: 
Thursday, June 1, 2023
Mental Health, FDA, Public Relations, Investor Relations, Communications, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Central nervous system, Depression, Anxiety, COVID-19, Fear, Woman, SAD, Headache, CNS, ASCP, Patient, LSAS, Annual general meeting, Social anxiety disorder, Poster, PH94B, Mental health, Society, Safety, Pharmaceutical industry, Nursing, Medical imaging

Over 30,000 doses of fasedienol were administered by patients during the study.

Key Points: 
  • Over 30,000 doses of fasedienol were administered by patients during the study.
  • The LSAS was the primary efficacy endpoint in all registration studies for the three FDA-approved treatments for adults with SAD.
  • The CGI-I results indicated 43% of the 218 patients assessed after three months were “much” or “very much” improved.
  • The PGI-C results indicated 44% of the 218 patients assessed after three months considered themselves “much” or “very much” improved.

Bionomics Announces Upcoming Poster Presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023
Central nervous system, BNC210, Anxiety, Acute, Psychopharmacology, SAD, BNO, NAM, CNS, ASCP, Annual general meeting, Social anxiety disorder, Society, Pharmaceutical industry, Bionomics

The presentation will include previously announced data from Phase 2 PREVAIL study of BNC210 for the acute treatment of SAD, which support the late-stage development of the drug for this indication.

Key Points: 
  • The presentation will include previously announced data from Phase 2 PREVAIL study of BNC210 for the acute treatment of SAD, which support the late-stage development of the drug for this indication.
  • Collectively, these analyses further support BNC210’s potential as a non-sedating anxiolytic for the acute treatment of SAD and may inform future registrational trial designs, including the selection of endpoints and population.
  • “We look forward to discussing these results with the global psychopharmacology community at ASCP, especially as we prepare for an FDA End of Phase 2 meeting to discuss a registrational program in SAD.
  • Title: A Phase 2, Double-Blind, Placebo-Controlled Study for BNC210, an alpha7 Nicotinic Receptor Negative Allosteric Modulator (NAM) for the Acute Treatment of Social Anxiety Disorder (PREVAIL): Top-Line Efficacy and Safety Results.

Vistagen to Present Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

Retrieved on: 
Tuesday, May 30, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Anxiety, ASCP, Social anxiety disorder, Central nervous system, Depression, SAD, PH94B, Society, Safety, CNS, Annual general meeting, Pharmaceutical industry

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 that safety and exploratory efficacy data from its Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of adults with social anxiety disorder (SAD) will be presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023.

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 that safety and exploratory efficacy data from its Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of adults with social anxiety disorder (SAD) will be presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023.

Enveric Biosciences Celebrates and Supports 2023 Mental Health Awareness Month

Retrieved on: 
Tuesday, May 2, 2023
Biotechnology, Pharmaceutical, Health, Phobia, Depression, Anxiety, Therapy, Anxiety disorder, Quality of life, Brain, Research, Mental Health Awareness Month, Drug design, Organization, Addiction, Patient, Panic disorder, Social anxiety disorder, Biology, Anxiety and Depression Association of America, Mental health, Pharmaceutical industry, Nursing

Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced its support of Mental Health Awareness Month this May as the company advances its novel development programs to improve the treatment of mental health disorders.

Key Points: 
  • Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced its support of Mental Health Awareness Month this May as the company advances its novel development programs to improve the treatment of mental health disorders.
  • Enveric is developing therapies that target the underlying biology of mental health conditions, with a focus on reducing symptoms and improving patients' overall well-being.
  • Enveric is planning to conduct a multi-cohort, dose-ascending study Phase 1 clinical trial of EB-373 to evaluate the drug’s safety and tolerability.
  • “We are proud to join other leaders and organizations in the mental health community to commemorate May as Mental Health Awareness Month,” said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences.

Quarterly Activities and Cashflow Report

Retrieved on: 
Friday, April 28, 2023
Regulation of tobacco by the U.S. Food and Drug Administration, Executive, Employment, Central nervous system, BNC210, Quarter, Post-traumatic stress disorder, Extraordinary general meeting, BNO, SAD, ASX, Research, Bionomics, CNS, Patient, Webcast, Social anxiety disorder, FDA, Food, PTSD, Non-executive director, Corporate development, Pharmaceutical industry, Cryptocurrency

On 30 January 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 December 2022.

Key Points: 
  • On 30 January 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 December 2022.
  • On 23 February 2023, Bionomics released its Half-Year Report for the half-year ended 31 December 2022.
  • Finally, the Company has sufficient cash runway to support its ongoing activities through its anticipated milestones and into 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.

Bionomics Announces the Completion of Enrollment in Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)

Retrieved on: 
Thursday, April 27, 2023
Central nervous system, BNC210, Post-traumatic stress disorder, SAD, BNO, CNS, Patient, Social anxiety disorder, PTSD, Pharmaceutical industry, Bionomics

“2023 is on track to be a pivotal and milestone-rich year for Bionomics.

Key Points: 
  • “2023 is on track to be a pivotal and milestone-rich year for Bionomics.
  • Completing enrollment in the Phase 2b ATTUNE trial paves the way for a timely topline readout and highlights our mid- and late-stage clinical development capabilities.
  • “Our momentum continues to grow following promising results with BNC210 in our Phase 2 PREVAIL study in Social Anxiety Disorder (SAD).
  • Together, our SAD and PTSD programs hold the promise of transforming the treatment paradigm in two highly prevalent neuropsychiatric disorders.”

Vistagen Presents New Fasedienol (PH94B) Research at 2023 Anxiety and Depression Association of America Conference

Retrieved on: 
Wednesday, April 19, 2023
Research, Mental Health, Medical Supplies, Neurology, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Volunteering, Neuron, Central nervous system, Depression, MOA, Anxiety, SAD, Brain, Cell, CNS, Translational medicine, Anxiety and Depression Association of America, Central nervous system disease, Social anxiety disorder, ADAA, PH94B, Conference, Safety, Pharmaceutical industry

Findings from the study demonstrate local metabolism and clearance of fasedienol from the nasal passages.

Key Points: 
  • Findings from the study demonstrate local metabolism and clearance of fasedienol from the nasal passages.
  • This discovery of the local nasal clearance of fasedienol may explain prior research findings that fasedienol is absent from systemic circulation and from the brain after intranasal administration, contributing to its favorable safety profile in all clinical studies to date, which studies have involved over 30,000 doses of fasedienol administered to adults with SAD.
  • In the study, cells were extracted from the epithelial lining of the dorsal nasal septum of each nasal passage in healthy adult volunteers.
  • Results from incubation of fasedienol with human nasal epithelial cells show that it is progressively metabolized and cleared from the nasal passages by P450-CYP enzymes expressed in nasal epithelial cells, including chemosensory cells, after intranasal spray administration.