FDA Grants Expanded Access for Lipella’s LP-310 to Treat Oral Lichen Planus

In a significant step forward for patients with oral lichen planus (OLP), Lipella Pharmaceuticals has received FDA approval for an Expanded Access Program (EAP) for LP-310. This breakthrough oral rinse therapy is designed to provide much-needed relief for individuals suffering from OLP, a painful chronic inflammatory condition affecting millions. With no FDA-approved treatments currently available, the approval offers new hope to patients dealing with burning pain, swollen tissues, and persistent sores. The EAP allows eligible patients to access LP-310 outside of clinical trials, reflecting the urgent need for alternative treatment options.

Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella, expressed his enthusiasm for the FDA's decision, highlighting the company’s dedication to addressing unmet medical needs. “This approval marks a critical milestone in our commitment to improving the lives of those affected by oral lichen planus,” said Dr. Chancellor. By expanding patient access to LP-310, Lipella aims to fill a crucial gap in OLP treatment while continuing clinical development efforts. The company remains focused on advancing innovative therapies that bring real solutions to patients struggling with challenging medical conditions.