Lexicon Pharmaceuticals announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the 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.
“Our End-of-Phase 2 meeting with FDA was productive and provided Lexicon with the insights needed to design a robust Phase 3 program, with the goal of making the first non-opioid DPNP medicine available to patients in over two decades,” said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Furthermore, the FDA did not require any unanticipated preclinical or clinical studies that would be expected to complicate or delay the advancement of this program into Phase 3 development and a potential regulatory submission.”
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