Lexicon Pharmaceuticals has announced that its End-of-Phase 2 (EOP2) Meeting with the FDA for pilavapadin has concluded successfully, with the agency raising no objections to advance the non-opioid oral pain medication to phase 3.
Pilavapadin is a selective, investigational small molecule inhibitor of AAK1 that treats diabetic peripheral neuropathic pain (DPNP). It uses the novel target of neurotransmitters involved in pain signaling rather than opiate pathways. In preclinical studies, the drug was able to penetrate the central nervous system and reduced pain behavior in model of neuropathic pain.
Phase 3 trials will consist of two-arm registrational studies that compare a single daily dose of 10 mg to a placebo. The primary endpoint will be a comparison in the average daily pain score at baseline to week 12.