MDMA

PharmAla Biotech and Filament Health Announce Release of Second Batch of GMP MDMA Capsules

Retrieved on: 
Wednesday, November 15, 2023
Capsule, Interest, Health Canada, Research, CSE, GMP, OTCQB, Entrepreneurship, MDMA, Clinical trial, NEO, Patient, FH, Batch, Monash University, MDXX, Filament, Partnership, PTSD, Pharmaceutical industry, Dietary supplement

VANCOUVER, British Columbia, Nov. 15, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE:MDMA)(OTCQB:PMBHF), a Canadian biotechnology company dedicated to the research and development of clinical-grade LaNeo™ MDMA and novel MDXX compounds, and Filament Health Corp. ( OTCQB:FLHLF ) ( NEO:FH ) ( FSE:7QS ) (“Filament”), a clinical-stage natural psychedelic drug development company, today announced the GMP release of a second batch of MDMA capsules encapsulated at Filament’s Metro Vancouver facility.

Key Points: 
  • VANCOUVER, British Columbia, Nov. 15, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE:MDMA)(OTCQB:PMBHF), a Canadian biotechnology company dedicated to the research and development of clinical-grade LaNeo™ MDMA and novel MDXX compounds, and Filament Health Corp. ( OTCQB:FLHLF ) ( NEO:FH ) ( FSE:7QS ) (“Filament”), a clinical-stage natural psychedelic drug development company, today announced the GMP release of a second batch of MDMA capsules encapsulated at Filament’s Metro Vancouver facility.
  • “With a number of regulatory changes over the past 6 months, we are pleased to have seen strong demand for our LaNeo MDMA Capsules,” said Nick Kadysh, CEO at PharmAla Biotech.
  • “With this second released batch, we’ve been incredibly proud to continue our work with the team at Filament to execute manufacture of our second batch of capsules.
  • “There is significant demand for GMP MDMA drug product and we are proud to meet that need with our industry-leading manufacturing capabilities,” said Benjamin Lightburn, CEO and Co-Founder of Filament Health.

atai Life Sciences Reports Third Quarter 2023 Financial Results and Pipeline Highlights

Retrieved on: 
Tuesday, November 14, 2023
Sale, Acquisition, Safety, Pivotal, EGX, DMT, Entrepreneurship, Aes, Plasma, MDMA, Investment, Exercise, CIAS, Administration, Patient, QT, Research, Cognition, American College, G&A, Pharmacology, OTF, Permeability, Drug discovery, IB, TRD, PTSD, OUD, R, Neuroscience, Research and development, Mental health, AI, Poster, Taste, Pharmaceutical industry, Bank, Medicinal plants, Rare-earth element, Vaccine, Medical device, Psychopharmacology, Anorexia nervosa, Ibogaine

NEW YORK and BERLIN, Nov. 14, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported third quarter 2023 financial results and provided corporate updates.

Key Points: 
  • NEW YORK and BERLIN, Nov. 14, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported third quarter 2023 financial results and provided corporate updates.
  • The on-going Phase 2b study will evaluate 20mg and 40mg of RL-007 vs. placebo in patients with CIAS, with topline results expected in 2H 2024.
  • The poster will be presented at the American College of Neuropsychopharmacology (ACNP) annual meeting on Dec 5, 2023, 5:00 – 7:00 PM ET.
  • In November 2023, atai acquired all remaining outstanding shares of its subsidiary, DemeRx IB, Inc.

MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD

Retrieved on: 
Wednesday, December 13, 2023
Veterans, Defense, Other Health, Other Science, Pharmaceutical, Research, Software, Mental Health, Professional Services, Data Management, Science, Practice Management, Technology, Physical Therapy, Clinical Trials, Managed Care, Data Analytics, Health, Military, NDA, Medical writing, Post-traumatic stress disorder, PBC, MDMA, MMS, Psychotherapy, MAPS, FDA, New Drug Application, Contract research organization, PTSD, Pharmacovigilance, Pharmaceutical industry, Risk management

MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.

Key Points: 
  • MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with psychological intervention, which includes psychotherapy, or talk therapy, and other supportive services provided by a qualified healthcare provider.
  • MAPS PBC is developing investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder (PTSD).
  • Over a year ago, MAPS PBC selected MMS as its CRO partner for the development of NDA for MDMA-assisted therapy for PTSD.
  • We are grateful to MAPS PBC for entrusting MMS to be a part of this process.”
    As MAPS PBC’s CRO, MMS provided regulatory strategy and operations, pharmacovigilance, medical writing, and biometrics services.

Delix Therapeutics Awarded National Institutes of Health Grant to Advance Vital Research of Novel Neuroplastogen for Substance Use Disorders

Retrieved on: 
Wednesday, December 13, 2023
Science, Neurology, Research, Pharmaceutical, General Health, Health, Mental Health, Clinical Trials, Psilocybin, Cocaine, ATDP, Safety, Annual general meeting, Depression, Therapy, MDMA, DSM-IV codes, Patient, American College, Adderall, American College of Neuropsychopharmacology, Suds, Coronavirus Scientific Advisory Board, Ibogaine, NIH, Growth, Drug, Doctor of Philosophy, Psychiatry, Addiction, Bangladesh Technical Education Board, Ketamine, Pharmaceutical industry

DLX-007 is a novel, first-in-class, neuroplastogen being evaluated in a range of substance use disorders (SUDs), including opioid and stimulant use.

Key Points: 
  • DLX-007 is a novel, first-in-class, neuroplastogen being evaluated in a range of substance use disorders (SUDs), including opioid and stimulant use.
  • "With nearly 110,000 people dying from drug overdoses in America last year, substance use disorders remain a critical public health issue with limited treatment options.
  • Preliminary data are being generated for its potential efficacy in treating substance use disorders with cocaine, amphetamines, and multiple substances.
  • Delix is rapidly advancing its library of thousands of novel compounds into scalable, orally-bioavailable, take-home therapies.

Enveric Biosciences Announces Presentation of Two Posters at Canadian Chemical Engineering Conference (CSChE 2023)

Retrieved on: 
Friday, November 24, 2023
Biotechnology, General Health, Health, Mental Health, Psilocybin, Depression, New chemical entity, MDMA, Collection, Escherichia coli, Methamphetamine, Addiction, Therapy, Chemical substance, Conference, Anxiety, Synthetic biology, N-methyltransferase, Enzyme, Pharmaceutical industry, Fine chemical, Pioneers of Enver

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced the presentation of two posters at the Canadian Chemical Engineering Conference (CSChE 2023) which was held October 29th to November 1, 2023.

Key Points: 
  • Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced the presentation of two posters at the Canadian Chemical Engineering Conference (CSChE 2023) which was held October 29th to November 1, 2023.
  • First, the Enveric research team achieved the production of milligram quantities of pure compounds in small-scale batch fermentations.
  • The purified transamination products were converted to methamphetamine derivatives, including MDMA, by chemical reduction and N-methylation.
  • Using the synthetic biology platform, Enveric researchers were able to produce several previously undescribed, wholly novel products with important activities at target receptors.

Numinus Congratulates MAPS on its Application to the FDA for MDMA-Assisted Therapy for PTSD

Retrieved on: 
Wednesday, December 13, 2023
NDA, Priority review, Research, OTCQB, Food, Breakthrough therapy, OTCQX, MDMA, Learning management system, Psychotherapy, Toronto Stock Exchange, MAPS, Anime International Company, FDA, OTC Markets Group, PTSD, DEA, TSX, News, Gisela Falke von Lilienstein, Nursing, Pharmaceutical industry

"This great news for the psychedelic-assisted therapy community and the millions of Americans struggling with PTSD," said Payton Nyquvest, Founder and CEO of Numinus.

Key Points: 
  • "This great news for the psychedelic-assisted therapy community and the millions of Americans struggling with PTSD," said Payton Nyquvest, Founder and CEO of Numinus.
  • With its established clinic network and qualified professionals, along with our training pathway, Numinus is ready to offer MDMA-assisted therapy pending regulatory approvals."
  • As noted in the MAPS release : "With Breakthrough Therapy designation given to MDMA in 2017, MAPS PBC has requested the FDA grant Priority Review of the NDA.
  • Anticipating the demand for MDMA-Assisted Therapy, Numinus has recently expanded its Practitioner Training Program to address the potential shortfall in trained therapists.

Sunshine Earth Labs Ltd. and Optimi Health Corp. Announce Strategic Supply Agreement

Retrieved on: 
Thursday, December 7, 2023
Health Canada, Controlled Substances Act, Research, GMP, Food, MDMA, Ground substance, Sunlight, CSDA, Partnership, API, Prohibition of drugs

VICTORIA, BC, Dec. 7, 2023 /CNW/ - Sunshine Earth Labs Ltd. ("Sunshine Labs" or "Sunshine"), a Canadian-based biosciences company that aims to provide harm reduction products to the global market, today announced it has entered into a supply agreement with Optimi Health Corp. ("Optimi"), a leading end-to-end drug researcher and formulator licensed by Health Canada.

Key Points: 
  • VICTORIA, BC, Dec. 7, 2023 /CNW/ - Sunshine Earth Labs Ltd. ("Sunshine Labs" or "Sunshine"), a Canadian-based biosciences company that aims to provide harm reduction products to the global market, today announced it has entered into a supply agreement with Optimi Health Corp. ("Optimi"), a leading end-to-end drug researcher and formulator licensed by Health Canada.
  • Under terms of the agreement, Optimi will supply GMP quality-controlled Full Spectrum Active Pharmaceutical Ingredient (API) and encapsulated psilocybin product, and encapsulated MDMA from Optimi's 10,000 sq ft, state-of-the-art facility in Princeton, British Columbia.
  • "Our partnership with Optimi solidifies our commitment to delivering a safe and secure supply of controlled substances globally.
  • Mr. Ciprick and Mr. Edwards will host a joint webinar on Tuesday, December 12 at 4:30pm EST to discuss the benefits of the supply agreement for both companies.

ATMA and Cena Life Launch Nationwide Psychedelic-Assisted Therapy Healthcare Network

Retrieved on: 
Thursday, December 7, 2023
Psilocybin, KAP, Depression, Safety, Nursing, SAP, Transcranial magnetic stimulation, Physician, MDMA, Surgeon, Kat, AB, Patient, Ecosystem, Registered nurse, City, ATMA, Special access program, Anxiety, PTSD, Psychedelic drug, Therapy, PAT

CALGARY, AB, Dec. 7, 2023 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA") and Cena Life , forefront leaders in advancing psychedelic-assisted therapy (PaT) are  pleased to announce the opening of a  licensed Calgary Clinic and the establishment of the Psychedelic-Assisted Therapy Healthcare Network, a national clinical network for the emerging psychedelic-assisted therapy sector.

Key Points: 
  • CALGARY, AB, Dec. 7, 2023 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA") and Cena Life , forefront leaders in advancing psychedelic-assisted therapy (PaT) are  pleased to announce the opening of a  licensed Calgary Clinic and the establishment of the Psychedelic-Assisted Therapy Healthcare Network, a national clinical network for the emerging psychedelic-assisted therapy sector.
  • Like the evolving services in the Cena Life practice in Edmonton, the Calgary clinic will offer KaT, rTMS, SAP application support as well as regular psychological counselling services.
  • Together, we aim to create a network that prioritizes patient well-being while fostering a collaborative and supportive environment for practitioners.
  • Practitioners wishing to join The Psychedelic Healthcare Network are encouraged to take the required training for PaT in advance of practice.

Numinus Wellness Inc. Announces Fourth Quarter and Full Year Fiscal 2023 Results

Retrieved on: 
Wednesday, November 29, 2023
Psilocybin, EBITDA, Health Canada, Research, CCR, Ageing, MDMA, Learning management system, Clinical trial, PAT, MAPS, FDA, Trial of the century, Partnership, Conditional sentence, Growth, TSX, Payment card, Health care, Nursing, Pharmaceutical industry, Beauty salon, Phoenix

VANCOUVER, BC, Nov. 29, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months and fiscal year ended August 31, 2023 ("Q4 2023").

Key Points: 
  • VANCOUVER, BC, Nov. 29, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three months and fiscal year ended August 31, 2023 ("Q4 2023").
  • For the fiscal year ending August 31, 2023, revenue increased by 256.9% over the previous fiscal year.
  • On an annual basis, the gross margin was 36.1% in fiscal year 2023, compared to 27.4% in fiscal year 2022.
  • Numinus Bioscience will remain a legal entity under Numinus Wellness Inc., ensuring the Company will retain all intellectual property, patents, and regulatory licenses.

World’s First Observational Trial to Assess Real-World Efficacy of MDMA Treatment

Retrieved on: 
Thursday, November 9, 2023
Knowledge, Post-traumatic stress disorder, University of Calgary, MDMA, Veterans Affairs Canada, UC, Physician, OTC, Health Canada, Ethics, Special access program, Party, Research, RWE, CSE, Trauma, Nature, PTSD, Trial, Real, Clinical trial, Partnership, SAP, University, LOI, GMP, Safety, Collection, Patient, DSM-IV codes, Mental health, Senate, Pharmaceutical industry, Veteran

The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.

Key Points: 
  • The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances.
  • This trial will generate Real World Evidence (“RWE”) on the efficacy of MDMA in the treatment of Post-Traumatic Stress Disorder which may be submitted to Health regulators, including Health Canada and Veterans Affairs Canada.
  • As the trial is Observational in nature, no patients will be dosed as part of the trial’s protocol.
  • The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program.