Revive Therapeutics has added a MDMA microneedle patch to its portfolio of projects, partnering with PharmaTher to prepare a candidate for clinical development in multiple indications.
MDMA-assisted therapy has improved outcomes in post-traumatic stress disorder patients in a pair of phase 3 clinical trials, putting MAPS Public Benefit Corporation on course to file for approval later this year. However, Revive and PharmaTher see opportunities to improve on oral dosing of the molecule, leading them to collaborate on the development of a microneedle patch.
Revive partnered with PharmaTher in the belief the patch technology may enable flexible drug load capacity and combinations, controlled release delivery and desired pharmacokinetic and safety profiles that could overcome potential obstacles of oral dosing.
“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,” Revive CEO Michael Frank said in a statement.
PharmaTher has completed a preclinical study of its MDMA MN-Patch and plans to release the results early in the second quarter. The partners are already looking to the next steps, with Revive outlining plans to finalize a product and clinical development plan and start regulatory talks for future clinical trials in various indications.
Revive will evaluate the MDMA MN-Patch results for indications other than those it is targeting through its psilocybin program. The biotech’s work on the psychedelic medicine includes a project to develop an oral thin film strip formulation.