PH94B

Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region - ResearchAndMarkets.com

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목요일, 2월 8, 2024
Pharmaceutical, Health, Mental Health, Internet, Anxiety, DSM-IV codes, SAD, MDD, Research, PureTech Health, USD, Pharmacy, Social anxiety disorder, Prevalence, Patient, Distribution, GAD, PH94B, Ulotaront, FDA, Disorder, Tic disorder, PPD, Market, Depression, AbbVie, Zuranolone, MOA, Food, Commercialization, Therapy, TAAR1, Major depressive disorder, Sunovion, ADAA, Postpartum depression, NDA, Biogen, Conference, Pharmaceutical industry

The "Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Anxiety Disorders And Depression Treatment Market Analysis & Forecast 2024-2034: Market By Drug Class; By Indication; By Distribution Channel; and By Region" report has been added to ResearchAndMarkets.com's offering.
  • The global anxiety disorders and depression treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034.
  • Rising research & development activities for the development of innovative drugs for the treatment of anxiety & depression disorders is predicted to boost the market growth during the forecast period.
  • This application pertains to the use of cariprazine as an add-on treatment for individuals with major depressive disorder (MDD) who are already undergoing antidepressant therapy.

Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder

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월요일, 8월 7, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, Aes, SAD, Medicine, CNS, New York State Psychiatric Institute, Visit, Patient, LSAS, Anxiety disorder, Social anxiety disorder, PH94B, Social anxiety, Fasedienol, Safety, Pharmaceutical industry, Nursing, Medical imaging, SUDS

The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).

Key Points: 
  • The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).
  • The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033).
  • Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.
  • “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas.

Vistagen Provides Corporate Update and Reports Fiscal Year 2023 Financial Results

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수요일, 6월 28, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Hot, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, New Drug Application, COVID-19, Fear, Calendar, NDA, Woman, SAD, Fast Track, CNS, New York State Psychiatric Institute, Science, Phase 1, PALISADE, MDD, PH10, Patient, LSAS, Anxiety disorder, Menopause, Principal, PH94B, FDA, Safety, 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 provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 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 provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.
  • Positive results reported from Phase 2A study of PH80 in women diagnosed with vasomotor symptoms (hot flashes) due to menopause.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update for its fiscal year 2023 ended March 31, 2023.
  • In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Wednesday, June 28, 2023.

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

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목요일, 6월 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.

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

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화요일, 5월 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.

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

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수요일, 4월 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.

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

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수요일, 3월 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.

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

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화요일, 2월 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

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목요일, 2월 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.

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

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화요일, 1월 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.