Lipella Pharmaceuticals (Nasdaq: LIPO) has received FDA approval for an Expanded Access Program (EAP) for LP-310, an oral rinse designed to treat oral lichen planus (OLP). LP-310 offers a localized treatment approach for this chronic inflammatory condition, which affects approximately six million Americans and currently lacks FDA-approved therapies. The EAP allows patients with serious or life-threatening OLP to access LP-310 outside of clinical trials.
This FDA approval is crucial for OLP patients who currently have limited treatment options. The EAP provides access to a potentially effective therapy for a debilitating condition, offering hope for symptom relief where none previously existed. This also accelerates the gathering of real-world data on LP-310’s effectiveness and safety profile, potentially expediting its path to full FDA approval.
LP-310, an oral rinse formulation of tacrolimus, aims to minimize systemic exposure compared to existing treatments like steroids. A Phase 2a clinical trial is currently evaluating the safety, tolerability, and efficacy of three different doses of LP-310. This trial, taking place across seven U.S. sites, will provide essential data to support the drug’s further development.
This EAP approval signifies a significant advancement in OLP treatment. It provides immediate benefit to patients suffering from this condition while bolstering the clinical development of LP-310. This step forward could potentially lead to the first FDA-approved treatment for OLP, transforming the treatment landscape for millions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
