Lexicon Pharmaceuticals announced the presentation of patient-reported data on diabetic peripheral neuropathic pain (DPNP) at the 7th Annual Meeting of the American Society of Pain and Neuroscience (ASPN 2025), held July 17-20, 2025 at the Fontainebleau Miami Beach Hotel in Miami Beach, Florida. The study focuses on patient experiences with DPNP despite standard of care treatment to inform the clinical development of pilavapadin, the company's investigational non-opioid treatment.
Addressing an Overlooked Complication
DPNP represents a highly prevalent but often overlooked debilitating chronic complication of diabetes, causing burning pain, numbness, and other symptoms in the hands, feet, legs, and arms. The condition affects approximately 9 million patients in the United States, with previous research indicating that DPNP impacts an estimated 30% of patients with type 1 diabetes and 50% of patients with type 2 diabetes.
"Our study focusing on the patient experience with DPNP is meant to give a 'voice' to the nearly 100 million people worldwide who struggle with its impact on their activities of daily living," said M. Belinda Hardin, PharmD, BCPS, from Lexicon Pharmaceuticals. "We hope the new research raises awareness among healthcare professionals of the patient burden and empowers patients and caregivers to discuss treatment options with their providers."
Conference Presentation Details
The research was presented as a poster titled "Listening to Patients with Diabetic Peripheral Neuropathic Pain: Insights from a Patient Survey to Inform Advanced Clinical Development of Pilavapadin" on Saturday, July 19, from 9:40-10:00 a.m. ET in the Sparkle Ballroom (Poster #125), presented by M. Belinda Hardin, PharmD, BCPS, from U.S. Medical Affairs at Lexicon Pharmaceuticals.
Novel Therapeutic Approach
Pilavapadin (LX9211) represents a novel approach to treating neuropathic pain, discovered through Lexicon's unique gene science methodology. The investigational drug is a potent, once-daily, orally delivered, selective small molecule inhibitor of AAK1, a novel target for neuropathic pain that inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways.
Lexicon identified AAK1 through its target discovery efforts as a promising therapeutic approach for neuropathic pain treatment. Preclinical studies demonstrated that pilavapadin achieves central nervous system penetration and reduces pain behavior in neuropathic pain models without affecting opiate pathways.
Clinical Development Progress
The efficacy, safety, and pharmacokinetics of pilavapadin in DPNP were evaluated in the Phase 2a proof-of-concept RELIEF-DPN-1 study. The trial met its primary endpoint of reducing average daily pain score (ADPS) at week 6 compared to placebo and demonstrated substantial and consistent benefits in addressing DPNP symptoms, including burning pain and pain interference on sleep.
Based on these promising results, pilavapadin has received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP, which could expedite the regulatory review process.
Company Background
Lexicon Pharmaceuticals operates as a biopharmaceutical company focused on pioneering medicines that transform patients' lives. Through its Genome5000™ program, the company's unique genomics target discovery platform has enabled scientists to study the role and function of nearly 5,000 genes, identifying more than 100 protein targets with significant therapeutic potential across various diseases.
The company maintains a pipeline of promising drug candidates in discovery and clinical and preclinical development stages, targeting neuropathic pain, hypertrophic cardiomyopathy, obesity, metabolism, and other therapeutic areas. Through precise protein targeting, Lexicon aims to discover and develop innovative medicines that treat diseases safely and effectively.
