Mira Pharmaceuticals reports in vitro drug release data for topical Ketamir-2

MIRA Pharmaceuticals (MIRA) announced the completion of in vitro release testing for its topical formulation of Ketamir-2. The formulation is under investigation for localized application in pain-related conditions. The IVRT study assessed a 5% ointment formulation of Ketamir-2 using a validated Franz diffusion cell model. The formulation demonstrated consistent and dose-proportional release across multiple concentrations. The active compound remained stable within a hydrophobic base, and testing parameters followed FDA-recommended guidance for topical product evaluation. MIRA is currently advancing preclinical studies to evaluate the topical formulation in models of inflammatory and neuropathic pain. The goal of these studies is to further characterize in vivo performance and inform potential clinical development strategies. The FDA has identified neuropathic pain as a serious condition for which expedited development programs-such as Fast Track and Breakthrough Therapy designation-may be applicable when supported by qualifying data. MIRA is evaluating whether the topical Ketamir-2 formulation may meet the requirements for such a designation as the program advances. In addition to the topical formulation, MIRA is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers. A Phase 2a study in diabetic neuropathy is planned to follow. Developing both systemic and localized formulations may provide greater optionality in addressing a range of pain-related conditions.