MDMA News: Optimi's New Drug Now Available, Revive Advances Transdermal Patch Evaluations

Considering MDMA will likely be the first psychedelic to receive FDA approval for psychotherapeutic use to treat serious mental health conditions such as PTSD, several publicly listed companies are developing related products such as next-generation psychedelics- or a new delivery system to the human body.

Optimi Health, Ready To Offer Novel MDMA Drug

Health Canada licensed psychedelics producer Optimi Health Corp. OPTHF has completed the first batch of its proprietary pre-clinical MDMA drug candidate to be used in drug development, clinical trials and individual patients authorized by Health Canada’s Special Access Program (SAP), as well as Australia’s Authorized Prescriber (AP) scheme as of July 1.

“Optimi felt it was crucial to fill the void that exists in accessibility to high-quality MDMA drug candidates,” said CEO Bill Ciprick referring to patients and providers anticipating access to psychedelic-assisted therapy. “An inherent level of trust in the safety and purity of the product being administered is essential.” 

Good Manufacturing Process (GMP)-compliant production of OPTI-MHCL took place in Optimi’s lab in Princeton, BC. In addition to on-site testing, the company submitted the product to third-party labs for an independent analysis. 

CSO Justin Kirkland said the company’s in-house technology guarantees “stable product and quality” enabling an optimized route for MDMA delivery. 

“We feel our proprietary MDMA is the way of the future, and this unique offering can position us as the number one supplier globally,” he stated, adding that controlling the supply chain makes the process “highly cost-effective, with minimal by-products and impurities.”

CEO Ciprick concluded that “the level of accountability, transparency, and oversight” involved in OPTI-MHCL’s development process gives Optimi “full confidence that no other such GMP product currently exists on the Canadian or global markets.”

OPTI-MHCL can now be requested by licensed entities following an amendment to Optimi’s Controlled Drugs And Substances (CDS) dealer’s license. The offering will initially consist of 50mg, 80mg and 125mg dosage formats.

Revive Therapeutics Secures MDMA Supply For New Microneedle Patch

Life sciences psychedelics company Revive Therapeutics RVVTF has entered into a supply deal with MDXX-class molecules producer PharmAla Biotech Holdings for the latter’s GMP-compliant MDMA LaNeo towards the development of Revive’s microneedle patch delivery system. 

“Securing the supply of MDMA from PharmAla allows us to confidently advance our upcoming product and clinical development plans with our MDMA microneedle patch for mental health and abuse disorders,” said Revive CEO Michael Frank.

CEO Nick Kadysh of PharmAla added that “as countries like Australia move to allow the use of MDMA as a therapeutic molecule for the treatment of mental health disorders like PTSD, new drug product forms will be crucial.” He added that the new agreement could ultimately extend to supplying LaNeo MDMA in Revive’s new patch’s clinical stage.

See also: Australia: Health Insurer Would Provide First Psychedelics Therapy Coverage For Mental Health

Revive has recently entered into a research collaboration agreement with PharmaTher Holdings PHRRF to evaluate their microneedle technology with MDMA.

Photo: Benzinga edit with photo by Blue Planet Studio and Bacsica on Shutterstock.