MDMA

Optimi Health Signs Psilocybin Supply Agreement With New Zealand-Based Mātai Medical Research Institute

Retrieved on: 
Tuesday, April 9, 2024
Psilocybin, First Nations, Wharerātā, Certificate, Patient, Ethics, FRA, COA, Synthetic, Health Canada, Trial of the century, GMP, Clinical trial, Ground substance, Safety, MDMA, Medsafe, Medicine, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.
  • This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts.
  • Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract.
  • Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance.

Cortexa Commences Manufacturing GMP LaNeo™ MDMA in Australia

Retrieved on: 
Friday, April 5, 2024
Psychiatry, Growth, Capsule, Research, MDXX, GMP, OTC, MDMA, Pharmaceutical industry

TORONTO, April 05, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that, in another Australian first, its joint venture, Cortexa Pty.

Key Points: 
  • TORONTO, April 05, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that, in another Australian first, its joint venture, Cortexa Pty.
  • Ltd. (“Cortexa”), is proud to have commenced batch manufacturing of GMP LaNeo® MDMA 40mg capsules to support both clinical trials and clinical use under the TGA’s Authorised Prescriber pathway.
  • In doing so, Cortexa achieves another significant milestone, domestic Australian manufacturing, further strengthening its position as a leader in the Australian psychedelic landscape by executing on its plan to develop a reliable local supply.
  • After a comprehensive due diligence process, Cortexa is pleased to announce it has entered an exclusive arrangement with Perth-based contract manufacturer Optima Ovest (Optima).

Optimi Health Receives Finished Product Test Results and Certificate Of Analysis for GMP Natural Psilocybin Extract

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, Psilocybe, Organization, Documentation, Learning, Certificate, Patient, Research, Good manufacturing practice, FRA, COA, International Council, Health Canada, GMP, Data collection, Quality, Harmonization, Ground substance, GACP, Water, Safety, ICH, MDMA, Good

Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.

Key Points: 
  • Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.
  • The third-party COA confirms critical information regarding potency, water content, microbial content, and heavy metal content, ensuring that the Natural Psilocybin Extract meets the predetermined specifications.
  • The completion of both extract validation and finished product testing aligns with Optimi's goal of advancing the drug candidate, marking significant progress toward its eventual release for human consumption.
  • “Obtaining successful results on the validation batches of psilocybin extract speaks to Optimi’s dedication to developing a repeatable, quality focused manufacturing process.

PsyCan Welcomes Expansion of Insurance Coverage for Psychedelic-Assisted Therapy in Alberta

Retrieved on: 
Tuesday, April 2, 2024
Psilocybin, FAQ, Therapy, LSD, COVID-19, Patient, PAT, DMT, Private sector, Doctor of Philosophy, Insurance, Psychology, MDMA, FDA, Nursing

OTTAWA, April 02, 2024 (GLOBE NEWSWIRE) -- PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine industry, welcomes the expansion of insurance coverage for psychedelic-assisted therapy (PaT) led by the Alberta Blue Cross.

Key Points: 
  • OTTAWA, April 02, 2024 (GLOBE NEWSWIRE) -- PsyCan, the not-for-profit trade association for the legal Canadian psychedelic medicine industry, welcomes the expansion of insurance coverage for psychedelic-assisted therapy (PaT) led by the Alberta Blue Cross.
  • “We welcome Alberta Blue Cross as the first major provincial insurer to cover Psychedelic-Assisted Therapy in all of its forms,” said Philippe Lucas, PhD, President of SABI Mind, a psychedelic clinic group based in Alberta.
  • In fall 2022, Alberta became the first province to regulate psychedelic-assisted therapy for mental health treatments, and in a recent FAQ to healthcare providers, the Alberta Blue Cross explained that claims for psychedelic therapy in Alberta are eligible for reimbursement under plan members’ drug and psychology benefits.
  • We call on other insurers, both in the public and private sector to follow the example set by Alberta Blue Cross.”

Optimi Health Confirms Presenting Sponsorship at the 4th Annual Psychedelic Therapeutics and Drug Development Conference

Retrieved on: 
Thursday, March 28, 2024
Tel Aviv University, EST, Conference, Research, Good manufacturing practice, FRA, Health Canada, GMP, Ground substance, Safety, API, Good, MDMA, Therapy, Psychedelic drug, Drug development, Pharmaceutical industry

VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, proudly announces its role as a Presenting Sponsor at the highly anticipated 4th Annual Psychedelic Therapeutics and Drug Development Conference.

Key Points: 
  • VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, proudly announces its role as a Presenting Sponsor at the highly anticipated 4th Annual Psychedelic Therapeutics and Drug Development Conference.
  • The 4th Annual Psychedelic Therapeutics and Drug Development Conference convenes renowned researchers and esteemed leaders from academia, industry, non-profit organizations, and government sectors to explore the challenges and opportunities inherent in the research and development of psychedelic therapies for various health conditions with significant unmet needs.
  • “We believe this conference serves as an excellent platform for us to engage with key stakeholders, exchange ideas, and drive innovation in the field of psychedelic therapeutics,” he added.
  • Optimi delegates will be available at the conference to host networking sessions for those seeking more information about the company's GMP and API drug products.

Patent Allowance Granted for ALA-002 Composition by US Patent and Trademark Office

Retrieved on: 
Wednesday, March 27, 2024
Research, Social anxiety, Composition, Brain, NCE, IPON, Environment, Patent, Incidence, Patient, University, Hyperthermia, Autism spectrum, MDXX, The central science, United States patent law, General Population (album), Test, IP, OTC, Spectrum, MDMA, Intellectual property, FDA, ASD, Food, Pharmaceutical industry

Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA.

Key Points: 
  • Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA.
  • PharmAla’s patent application included in-vivo experimental animal data, which is generally held to be stronger evidence than computational, or in-silico, modeling.
  • The Company intends to pursue its own clinical research with the novel composition, either alone or with an out-licensing partner.
  • “We are incredibly pleased that USPTO has issued an allowance for the granting of the Composition of Matter patent for ALA-002.

PharmAla Biotech Signs Sale Agreement with Numinus

Retrieved on: 
Tuesday, March 26, 2024
MDXX, MBDB, GMP, TSX, OTCQX, Clinical trial, OTC, MDMA, ABA, Biology, Poster, Pharmaceutical industry

TORONTO, March 26, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA, OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it had entered into a binding sales agreement with Numinus Wellness Inc. (“Numinus”) (TSX: NUMI, OTCQX: NUMIF) to provide its GMP LaNeo™ MDMA for a prospective clinical trial.

Key Points: 
  • TORONTO, March 26, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA, OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to announce that it had entered into a binding sales agreement with Numinus Wellness Inc. (“Numinus”) (TSX: NUMI, OTCQX: NUMIF) to provide its GMP LaNeo™ MDMA for a prospective clinical trial.
  • “PharmAla wishes Numinus success in their clinical trial application, and looks forward to supporting them in their efforts,” said Nick Kadysh, Founding CEO, PharmAla Biotech.
  • The poster, entitled In Vivo Characterization of MBDB and its Enantiomers in C57 and Autism-like BTBR Mice, presents key findings from the development of PharmAla’s proof-of-concept rodent data for its ABA molecule family.
  • “We thank Dr. Fantegrossi for his exceptional and diligent work, and look forward to receiving academic community feedback on our findings thus far,” said Dr. Harpreet Kaur, Vice President of Research, PharmAla Biotech.

Optimi Health to Supply MDMA for Psychedelic Research at Tel Aviv University

Retrieved on: 
Tuesday, March 26, 2024
Tel Aviv University, Interdisciplinarity, Mental health, Research, FRA, Health Canada, Abstract, GMP, Quality, Ground substance, API, MDMA, Psychedelic drug, Pharmaceutical industry

In this collaboration, Optimi will supply IPR-TLV with MDMA, which was made from in-house produced active pharmaceutical ingredient (API), to support the institute's research investigating the effects of MDMA on animal models of alcohol addiction.

Key Points: 
  • In this collaboration, Optimi will supply IPR-TLV with MDMA, which was made from in-house produced active pharmaceutical ingredient (API), to support the institute's research investigating the effects of MDMA on animal models of alcohol addiction.
  • Optimi has received the import permit from IPR-TLV and is in the process of obtaining its export permit from Health Canada.
  • Expected to commence in the summer of 2024 and conclude in late 2025, this study aligns with Optimi's commitment to supplying MDMA to international researchers advancing mental health and addictions research.
  • Commenting on the collaboration, Optimi CEO Bill Ciprick expressed his enthusiasm, stating, "Our agreement with IPR-TLV signifies an exciting entry into the Israeli psychedelics research market for Optimi.

Patent Allowance Granted for P-1 Molecule by US Patent and Trademark Office

Retrieved on: 
Wednesday, March 20, 2024
Research, Composition, Nerve, Innovation, Psychological trauma, University, P-1, Patent, Stroke, MDXX, TBI, Cell membrane, United States patent law, Traumatic brain injury, OTC, MDMA, Pharmaceutical industry

“The molecule has an excellent therapeutic window; it shows a strong pro-social signal at dosage levels far below racemic MDMA.

Key Points: 
  • “The molecule has an excellent therapeutic window; it shows a strong pro-social signal at dosage levels far below racemic MDMA.
  • P-1 was submitted to the USPTO through the Patent Prosecution Highway program, allowing for accelerated patent examination.
  • As the molecule is ready for pre-clinical and clinical development, the Company has elected to change its designation to APA-001.
  • In addition there is potential applicability for the fear disorders often discussed in the context of MDMA.”

Cortexa Leads the World in First Supply of Psilocybin Under the TGA’s Authorized Prescriber Scheme

Retrieved on: 
Monday, March 18, 2024
Psilocybin, Depression, Patient, Research, MDXX, Sale, BHC, Ahmad Adaya, Prescription, GMP, Clinical trial, OTC, Authorization, MDMA, Special access program, Pharmaceutical industry

Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.

Key Points: 
  • Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.
  • The patient was being treated with Psilocybin for treatment resistant depression.
  • In doing so, Cortexa is now established as the only Australian company able to immediately supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s Authorised Prescriber Scheme.
  • Cortexa has created a national network of relationships with research institutes, key opinion leaders and emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.