Lexicon Pharmaceuticals to Present Pilavapadin Study Results at AAN Meeting
Lexicon Pharmaceuticals announced that results from its Progress Phase 2b study of pilavapadin in diabetic peripheral neuropathic pain, DPNP, supporting the selection of pilavapadin 10 mg as the optimal dose for Phase 3 development will be presented on Wednesday April 22, during the American Academy of Neurology, AAN, Annual Meeting. At the meeting, the company will also present results of an evaluation of pilavapadin on spasticity-related endpoints in preclinical models of multiple sclerosis and spinal cord injury. The congress is being held April 18-22 in Chicago, Illinois. In a session titled "Additional Efficacy Data Support Selection of Pilavapadin 10 mg for Phase 3 Development in DPNP: Results From PROGRESS," the company will present data from the study on pain outcomes as measured by the Brief Pain Inventory-Diabetic Peripheral Neuropathy patient reported instrument. Pilavapadin 10 mg achieved a nominally significant reduction in Average Pain at Week 8 versus placebo, with concordant improvements in Worst and Least Daily Pain, as measured by BPI-DPN. The 10 mg dose was generally well-tolerated over 8 weeks, with completion rates comparable to placebo and few discontinuations due to treatment emergent adverse events. Overall, these results provide additional support for the advancement of pilavapadin 10 mg into Phase 3 evaluation in DPNP.