MDMA Transdermal Patch Moves Toward First-In-Human Trials: Latest Development Update

Specialty drug delivery technology biopharma company Revive Therapeutics Ltd. RVVTF is undertaking research and development activities for its proprietary transdermal microneedle patch to deliver MDMA toward IND-enabling studies, supported by an exclusive supply deal with PharmaAla Biotech Holdings Inc. for the latter’s GMP-MDMA “LaNeo.”

The research is being led by Revive’s partner, PharmaTher Holdings PHRRF, which has completed a non-clinical study with Terasaki Institute for Biomedical Innovation (TIBI), the results of which will soon be shared. 

PharmaTher will finalize the product and clinical development plan after which both partners will start regulatory discussions for studies on several health indications as well as perform required studies towards commercialization in Australia.

The new MDMA patch, according to CEO Michael Frank, will enable flexible drug load capacity and combinations, delivering the psychedelic in a controlled and safe manner. It will potentially overcome obstacles associated with oral dosing and expand “the therapeutic utility of MDMA for mental health and abuse disorders.”

In addition to delivering MDMA, the transdermal patch is also being assessed for psilocybin, a psychedelic for which Revive is furthermore developing a novel oral thin film.

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Photo: Benzinga edit with photo by psychedelic DyrElena by Shutterstock and Wikimedia Commons.