Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) said it has initiated research and development of its novel transdermal microneedle patch to deliver 3,4-Methylenedioxy methamphetamine (MDMA).
Following the exclusive supply agreement with PharmaAla Biotech Holdings Inc to obtain PharmAla’s LaNeo, GMP source of MDMA, the company has purchased MDMA supply to support upcoming Investigational New Drug Application (IND)-enabling studies with the MDMA patch.
“Our clinical and commercial initiatives in broadening our psychedelic product portfolio with our novel MDMA microneedle patch offers a unique delivery method that could expand on the therapeutic utility of MDMA for mental health and abuse disorders,” said Michael Frank, CEO of Revive Therapeutics in a statement.
READ: Revive Therapeutics enrols first patient in psilocybin clinical study for methamphetamine use disorder
Recently, Revive Therapeutics announced a research collaboration agreement with PharmaTher Holdings to evaluate their microneedle patch technology with MDMA. PharmaTher has completed a non-clinical research study with Terasaki Institute for Biomedical Innovation (TIBI) evaluating the delivery of its MDMA patch.
Revive said research results from this study will be available early in the second quarter of 2023 and will be used to support future research studies in the US and potential commercial initiatives in Australia where MDMA can be available to specially-licensed psychiatrists to prescribe for certain conditions.
In addition, Revive said it will work with PharmaTher who will finalize a product and clinical development plan to initiate regulatory discussions for future studies in various indications where MDMA may have promise and to finalize certain studies to satisfy the regulatory requirements towards the company’s commercial objectives in Australia.
The company believes that the MDMA Patch may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles, which could potentially overcome obstacles associated with oral dosing.
Revive Therapeutics is a specialty pharmaceutical company focused on novel uses and delivery systems for psychedelics, cannabinoids, and small molecule drugs for unmet medical needs, including infectious diseases, rare disorders, and mental health and substance abuse conditions.
Currently, the company is exploring using Bucillamine as a potential treatment for COVID-19 in a Phase 3 clinical study and evaluating rare inflammatory disorders such as ischemia and reperfusion injury from organ transplantation, for which the company received FDA orphan drug status designation.
In addition, Revive is developing a novel psilocybin oral thin film and a transdermal microneedle patch to deliver psilocybin and MDMA.
Contact the author at jon.hopkins@proactiveinvestors.com