FDA Fast Tracks Potential Neuropathy Treatment
The designation has been granted to potentially treat neuropathic pain associated with diabetic peripheral neuropathy.
The Food and Drug Administration (FDA) has granted NYX-2925 (Aptinyx) Fast Track designation for the potential treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN).
The company announced its intention to advance the development of NYX-2925 in neuropathic pain based on successful results from preclinical studies. Its safety and tolerability is now currently being evaluated in a randomized, double-blind, placebo-controlled, Phase 1 trial in healthy volunteers. Aptinyx intends to initiate a Phase 2 study in 2017.
NYX-2925 is an oral, small-molecule modulator of the N-methyl-D-aspartate (NMDA) receptor designed to enhance synaptic plasticity or strengthen the network for neural cell communication.
Aptinyx Receives FDA Fast Track Designation for Development of NYX-2925 as Treatment for Neuropathic Pain Associated with Diabetic Peripheral Neuropathy [news release]. Evanston, Ill; Aptinyx Newsroom. September 13, 2016.