FDAnews Drug Daily Bulletin

FDA Awards Fast Track to Astellas-Chromocell Neuropathic Pain Reliever

Oct. 24, 2016

The FDA granted a Fast Track designation to drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy, being developed by Chromocell and Astellas Pharma. Chromocell recently began dosing in a Phase I clinical trial of the drug’s oral formulation.

The FDA's Fast Track program is for serious or life-threatening conditions and therapies that address unmet medical needs, and includes expedited development and review.

The compound is a selective, peripherally restricted inhibitor of NaV1.7, which has been shown to be efficacious in multiple animal models of human neuropathic and inflammatory pain. NaV1.7 is an ion channel involved in pain transmission, according to Chromocell.

View today's stories