Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain

Core Insights - Lexicon Pharmaceuticals has successfully completed the End-of-Phase 2 meeting with the FDA for pilavapadin, which is advancing into Phase 3 development for diabetic peripheral neuropathic pain (DPNP) [1][2] - The FDA raised no objections to the Phase 3 program, which will include two placebo-controlled studies comparing a 10 mg daily dose of pilavapadin to placebo [1][2] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [4] - The company has a pipeline of drug candidates in various stages of development, targeting conditions such as neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, and metabolism [4] Product Information - Pilavapadin is a once-daily, orally delivered small molecule inhibitor of AAK1, designed to treat neuropathic pain without affecting opiate pathways [3] - Preclinical studies have shown that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [3]