FDA Breakthrough status for Grunenthal drug candidate for CRPS

German family-owned drugmaker Grünenthal and Abiogen Pharma, privately held Italian pharmaceutical company, say that the US Food and Drug Administration has granted Breakthrough Therapy designation to neridronic acid, an investigational medicine, for the treatment of complex regional pain syndrome (CRPS), a serious, disabling orphan disease.

Today, with no FDA- or EMA-approved drug treatments, there is a clear need for effective treatment options to address this significant unmet medical need. CRPS is a debilitating condition characterized by severe, continuous, burning pain often occurring in an extremity after injury or surgery. It is one of the most painful conditions a patient can experience1.

The Breakthrough Therapy Designation is supported by data from a randomized, double-blind, placebo-controlled phase II clinical trial showing significant reduction in pain and symptoms of CRPS-I with neridronic acid treatment.