IPX056

IPX056 is an extended-release formulation of baclofen, a muscle relaxant and antispastic medication. It was developed by Impax Laboratories (now part of Amneal Pharmaceuticals) for the treatment of spasticity, particularly in patients with multiple sclerosis. The drug contains both immediate-release and sustained-release components, designed to provide improved control of spasticity symptoms and dosing convenience compared to conventional baclofen. Clinical trials have shown that IPX056 can reduce spasticity as measured by Ashworth scores, and may help reduce morning stiffness and nighttime awakenings in MS patients. According to the search results, IPX056 met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients. The study was a randomized, placebo and active comparator-controlled double-blind trial that enrolled 173 MS patients and included a seven-week open-label extension. The primary efficacy endpoint, a reduction in spasticity as measured by Ashworth score following a single dose, was statistically significant for IPX056 compared to placebo. The drug was generally safe and well-tolerated in the study. As of the search results provided, IPX056 was still in development, with the FDA requesting additional longer-term controlled clinical data on safety and efficacy before approval. The company was planning to design a trial to collect this data, which the FDA agreed to review as a Special Protocol Assessment (SPA).

Other names

Baclofen extended-releaseExtended-release baclofen