Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus

Core Insights - The U.S. FDA has granted approval for an Expanded Access Program for LP-310, an oral rinse formulation aimed at treating oral lichen planus (OLP) [1][4] - LP-310 is designed to provide targeted relief for OLP patients while minimizing systemic exposure, addressing a significant unmet medical need as there are currently no FDA-approved therapies for this condition [2][4] Company Overview - Lipella Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs by reformulating active agents in existing generic drugs [6] - The company is currently conducting a Phase 2a multicenter, dose-ranging clinical trial for LP-310 to evaluate its safety, tolerability, and efficacy in adult participants with symptomatic OLP [5] Product Details - LP-310 is an oral rinse formulation of tacrolimus, targeting inflammation and immune response in OLP patients, and is designed to minimize systemic exposure, reducing risks associated with long-term steroid use [5] - The ongoing clinical trial includes three dose levels (0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites [5]