MDD

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

Retrieved on: 
Monday, April 1, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Depression, Psychiatry, Brain, Mirai, Medication, MDD, Patient, DSM-IV codes, Therapy, Cognition, Regulation, Otsuka Pharmaceutical, MADRS, Multimedia, Clinical Global Impression, Emotion, Food, Pharmaceutical industry

Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.

Key Points: 
  • Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.
  • “While traditional approaches are often effective, many are left with only a partial response to treatment.
  • “The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder.
  • Rejoyn does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.

Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Depression, Atypical depression, Data analysis, MDD, Patient, Beckley Foundation, DSM-IV codes, TRD, Treatment, Drug development, Safety, Phase, FDA, 5-MeO-DMT, Pharmaceutical industry

95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .

Key Points: 
  • 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .
  • Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours.
  • Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity.
  • The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD).

Alto Neuroscience Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 21, 2024
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Modafinil, Research, Depression, EEG, DSM-IV codes, Histamine, Brain, Regenerative medicine, CFO, NMDA, MDD, Partnership, Patient, CNS, CIAS, Neuroscience, CIRM, Anhedonia, IPO, PDE4, Overalls, IND, Biogen, Cognition, Johnson & Johnson, Central nervous system disease, Pharmaceutical industry

Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the full year ended December 31, 2023, and highlighted recent corporate progress.

Key Points: 
  • Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today reported financial results for the full year ended December 31, 2023, and highlighted recent corporate progress.
  • In January 2023, Alto reported positive results from a Phase 2a study in which patients with MDD and a cognitive biomarker signature were identified as more responsive to ALTO-100.
  • Alto is currently evaluating ALTO-100 in a 266-patient Phase 2b study in MDD patients characterized by the cognitive biomarker.
  • The increase was primarily attributable to costs associated with the Phase 2a clinical studies for ALTO-100 and ALTO-300, which were completed in 2023.

Usona Institute Announces Launch of uAspire Phase 3 Clinical Trial Investigating Psilocybin for Major Depressive Disorder

Retrieved on: 
Wednesday, March 20, 2024
Mental Health, Health, Clinical Trials, Research, Pharmaceutical, Science, MDD, Efficacy, Trial of the century, DSM-IV codes, Pharmaceutical industry

Usona Institute announces the launch of its Phase 3 clinical trial, titled "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)."

Key Points: 
  • Usona Institute announces the launch of its Phase 3 clinical trial, titled "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)."
  • Known as the uAspire trial, its launch represents the beginning of an important next stage in the development of psilocybin as a potential therapeutic option for those diagnosed with MDD.
  • "The initiation of the Phase 3 uAspire trial marks an important milestone in the clinical development of psilocybin as a potential new treatment for major depressive disorder," says Dr. Mike Davis, Chief Medical Officer at Usona Institute.
  • "Following the robust safety and efficacy findings from our Phase 2 study PSIL201, the uAspire trial is designed to deepen our understanding of psilocybin’s treatment durability and long-term safety.

Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design

Retrieved on: 
Thursday, March 14, 2024
Mental Health, Finance, FDA, Clinical Trials, Professional Services, Biotechnology, Alternative Medicine, Health, Pharmaceutical, Depression, Week, DEA, BTD, Inc., MDD, Patient, Accelerated approval (FDA), DSM-IV codes, Suicidal ideation, Behavior, Priority review, Drug development, Major depressive disorder, Pharmaceutical industry

The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design.

Key Points: 
  • The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design.
  • The Company intends to commence enrollment for the multinational, multisite Phase 3 program in mid-year 2024.
  • The Company has engaged Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder.
  • Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational Phase 3 program around mid-year,” said Doug Drysdale, Chief Executive Officer of Cybin.

Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder

Retrieved on: 
Wednesday, March 13, 2024
Alternative Medicine, Mental Health, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, JAMA, Depression, Disability, Conference, BTD, Breakthrough therapy, Massachusetts General Hospital, Inc., Psychiatry, Clinical, Grammatical mood, Appetite, MDD, Data analysis, Patient, Knowledge, Disease, Causality, Sleep, Anhedonia, DNB, DSM-IV codes, MBBS, Suicidal ideation, Behavior, Cognition, Event, Hospital, Drug development, Safety, Injury, Multimedia, Plasma protein binding, Sadness, Lancet, BMJ, Pharmaceutical industry

If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.

Key Points: 
  • If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
  • The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies.
  • With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously.
  • (2022) Response to acute monotherapy for major depressive disorder in randomized, placebo-controlled trials submitted to the US Food and Drug Administration: individual participant data analysis.

Dr. Vince Clinical Research Announces First Dosing in a Phase II Study in Patients With Depression

Retrieved on: 
Wednesday, March 13, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Professional Services, Clinical Trials, Depression, Brain, Communication, MDD, Partnership, Patient, DSM-IV codes, Clinical trial, Safety, Pharmacology, Phase, Medical director, Dissociative, Pharmaceutical industry

Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).

Key Points: 
  • Dr. Vince Clinical Research (DVCR) , a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD).
  • MDD is estimated to affect over 17 million adults in the United States, with approximately 30% of these patients being resistant to treatment.
  • Supernus Pharmaceuticals , in collaboration with Navitor Pharmaceuticals , is developing SPN-820 to provide a rapid-onset antidepressant response via oral administration for adult patients with treatment-resistant depression.
  • We are appreciative of the partnership with DVCR for our SPN-820 program.”
    The Phase II study is being conducted at six U.S. sites and is expected to enroll approximately 50 adult MDD patients.

Cybin to Host Conference Call and Webcast to Provide Program Update for CYB003

Retrieved on: 
Wednesday, March 13, 2024
Alternative Medicine, Mental Health, Health, Clinical Trials, General Health, Biotechnology, MDD, Webcast, Conference, Event, Inc.

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that it will host a conference call and webcast at 8:30 a.m.

Key Points: 
  • Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that it will host a conference call and webcast at 8:30 a.m.
  • ET on Wednesday, March 13, 2024.
  • The Company will provide a program update on CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of MDD, including 4-month durability results from the Company’s Phase 2 trial.
  • Conference Call and Webcast Details:
    The archived webcast will also be available on the Company’s investor relations website on the Events & Presentations page.

PsyRx Advances Clinical Trial Exploration with Successful Completion of Toxicological Safety Study in Rats

Retrieved on: 
Monday, March 25, 2024
Pharmacy, MDD, SSRI, Human, Patient, Cyclothymia, Hope, Research, Animal, Major depressive disorder, TEL, Clinical trial, Ibogaine, Safety, Pharmaceutical industry

TEL AVIV, Israel, March 25, 2024 /PRNewswire/ -- PsyRx, a leading innovator in pharmaceutical research, is pleased to announce the successful conclusion of the live phase of a toxicological safety study involving the combined treatment of SSRI plus ibogaine.

Key Points: 
  • TEL AVIV, Israel, March 25, 2024 /PRNewswire/ -- PsyRx, a leading innovator in pharmaceutical research, is pleased to announce the successful conclusion of the live phase of a toxicological safety study involving the combined treatment of SSRI plus ibogaine.
  • This groundbreaking study is a pivotal step in the company's ongoing evaluations for conducting a clinical trial in humans, specifically focusing on patients suffering from Major Depressive Disorders (MDD).
  • During the 14 consecutive treatment days, the study examined the safety of administering the combined treatment at three different dose levels—low, medium, and high.
  • The successful completion of this toxicological safety study marks a significant achievement in the pursuit of improving the lives of individuals affected by MDD.

ColdZyme® certified under the new EU medical device regulation (MDR)

Retrieved on: 
Monday, March 11, 2024
Certification, Infection, MDD, Sore throat, History, Classification, Virus, Ill, MDR, Eurofins Scientific, Safety, Trypsin, Medical device

Eurofins, a European approved notified body for medical devices, has certified the ColdZyme® product line MDR (class III) according to the European Union medical device regulation.

Key Points: 
  • Eurofins, a European approved notified body for medical devices, has certified the ColdZyme® product line MDR (class III) according to the European Union medical device regulation.
  • MDR replaces the previous EU regulation MDD and imposes stricter requirements on evidence of clinical validity, safety design, and market surveillance.
  • ColdZyme is one of the first flu- and cold products to be certified under the new regulation.
  • "This certification process has meant extensive review of our quality processes and product data in accordance with the medical device legislation.