The biopharmaceutical company Aptinyx Inc. has announced its intention to develop NYX-2925, an N-methyl-D-aspartate (NMDA) receptor modulator, for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). The FDA has designated the investigation of NYX-2925 in this indication as a fast-track development program. Fast-track status is intended to expedite the development and regulatory review of therapeutic programs that seek to address significant unmet medical needs.
The decision to advance NYX-2925 in neuropathic pain was supported by results from preclinical studies, which will be presented at the 16th World Congress on Pain in Yokohama, Japan. The safety and tolerability of NYX-2925 is currently being evaluated in a phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers.
DPN is estimated to affect up to 70% of the approximately 30 million people with diabetes in the United States. About half of these patients experience associated neuropathic pain. Patients and caregivers attempt to manage this pain through the use of pharmaceuticals, medical devices, exercise, complementary and alternative medications, and even surgery. However, even the most effective therapies offer only modest and inconsistent relief, and most existing pharmacotherapies are associated with severe adverse effects.
Source: Aptinyx; September 13, 2016.