Lexicon Pharmaceuticals Completes Phase 2 Meeting With FDA For Pilavapadin In Diabetic Peripheral Neuropathic Pain

Lexicon Pharmaceuticals, Inc. -3.05%

Lexicon Pharmaceuticals, Inc.

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Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) for pilavapadin in diabetic peripheral neuropathic pain (DPNP). During the meeting, the FDA raised no objections to the advancement of pilavapadin into Phase 3 development, which would include two placebo-controlled, 12-week, two arm registrational studies comparing the 10 mg daily dose to placebo. The primary endpoint of the Phase 3 studies will be the change in average daily pain score (ADPS) from baseline to Week 12.