Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) has entered into a research collaboration agreement with PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) to evaluate the delivery of 3,4-Methylenedioxymethamphetamine (MDMA) using PharmaTher’s novel microneedle patch delivery technology. MDMA is expected to be one of the first drugs in the psychedelic industry to get FDA approval.
Currently, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) has completed two confirmatory Phase 3 trials of MDMA-assisted therapy for PTSD to potentially support its new drug application to be filed with the U.S. Food and Drug Administration (FDA) in 1H-2023. The FDA decision for potential approval of MDMA-assisted therapy for PTSD is expected in 2024.
Revibe said it believes that the MDMA MN-Patch may enable a flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles which could overcome the potential obstacles of oral dosing.
Revive CEO Michael Frank said, “We are excited about the potential of the MDMA microneedle patch, which will complement our psilocybin programs for mental health and abuse disorders. We look forward to advancing the MDMA patch program that could fill the gaps that we believe could offer an advantage to oral MDMA treatments.”
PharmaTher has completed a non-clinical research study evaluating the delivery of its MDMA MN-Patch. Research results from this study will be available in early Q2-2023 and will be used to support a potential human clinical study. Based on the results, Revive and PharmaTher will finalize a product and clinical development plan to initiate regulatory discussions for future clinical studies in various indications where MDMA may have promise, including depression, anxiety, abuse disorders (i.e. eating, alcohol and drug use), and post-traumatic stress disorder (“PTSD”).
PharmAla To Supply MDMA
PharmAla Biotech Holdings Inc. (CSE: MDMA) announced that it has agreed to be an exclusive supplier of both GMP LaNeo MDMA and Engineering MDMA to Revive Therapeutics. PharmAla manufactures GMP MDMA and says it is the first company to make available to customers two clinical-grade Psychedelic APIs. PharmAla said it is a registered supplier to customers on 3 different continents.
“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,” said Nick Kadysh, CEO of PharmAla. “We’re proud to be able to offer our engineering MDMA to Revive in their development of an MDMA microneedle patch, and to ultimately supply them with LaNeo GMP MDMA as their development accelerates into human use.”
“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’s Frank.