Lexicon Pharmaceuticals Inc. (LXRX) announced that the U.S. FDA raised no objections to advancing Pilavapadin into Phase 3 development following a successful End-of-Phase 2 meeting for the treatment of diabetic peripheral neuropathic pain.
The agency agreed that Lexicon may proceed with two placebo-controlled, 12-week registrational Phase 3 studies evaluating a 10 mg once-daily dose of Pilavapadin. The primary endpoint for both trials will be the change in average daily pain score from baseline to Week 12.
Diabetic peripheral neuropathic pain (DPNP) is a chronic and often debilitating complication of diabetes, characterized by persistent nerve pain that can significantly impair daily functioning. Current treatment options frequently provide incomplete relief or carry tolerability challenges, underscoring the need for new non-opioid therapies.
Pilavapadin is an investigational, orally delivered small-molecule inhibitor of AAK1, a novel target involved in neuropathic pain signaling.
Preclinical studies demonstrated central nervous system penetration and reductions in pain-related behavior without affecting opioid pathways, supporting its potential as a differentiated treatment option.
Lexicon said the FDA did not request any additional unexpected preclinical or clinical studies that would delay the transition into Phase 3 or a future regulatory submission.
The company noted that the meeting provided clarity needed to design a robust late-stage program aimed at delivering the first non-opioid DPNP therapy in more than two decades.
LXRX has traded between $0.28 and $1.66 over the past year. The stock is currently trading at $1.49, up 13.63%.
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