Mundipharma, Purdue Pharma’s development and commercialization deal for sigma-1 antagonist

Mundipharma Medical Company Limited and the independent associated company, Purdue Pharma L.P., announced that, following completion of phase II studies, they have exercised their option and taken over full responsibility from Laboratorios Esteve, S.A.U (ESTEVE) for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist (S1A or MR309/E-52862).

Mundipharma Medical Company Limited and the independent associated company, Purdue Pharma L.P., announced that, following completion of phase II studies, they have exercised their option and taken over full responsibility from Laboratorios Esteve, S.A.U (ESTEVE) for the clinical, regulatory and commercial development of a potential first-in-class sigma-1 antagonist (S1A or MR309/E-52862).

The comprehensive phase I program for MR309/E-52862 evaluated the safety, tolerability, pharmacodynamics and pharmacokinetics.

Phase II clinical studies conducted in patients treated with MR309/E-52862 evaluated the efficacy profile in the treatment peripheral neuropathy of different etiologies (including from diabetic and post-surgical origins) as well as in moderate to severe acute post-operative pain. The results of these studies are pending publication. Mundipharma will now take the programme forward into additional clinical studies to support the ongoing development in multiple models of neuropathy and future registration and commercialization.

The Sigma-1 antagonism mechanism and MR309/E-52862 specifically promising in treating pain. This acquisition further expands our pain pipeline with another potentially innovative non-opioid, non-NSAID treatment. Therefore, this is a strategic fit to Mundipharma, Purdue Pharma’s pipeline.