In a significant development for oral lichen planus (OLP) patients, the U.S. Food and Drug Administration has approved an Expanded Access Program (EAP) for Lipella Pharmaceuticals' LP-310, offering new hope for individuals suffering from this chronic inflammatory condition.
Understanding the Medical Need
Oral lichen planus affects approximately 6 million Americans, causing debilitating symptoms including burning pain, white patches, swollen tissue, and open sores in the mouth's mucous membranes. Currently, there are no FDA-approved therapies for this condition, highlighting a critical gap in treatment options.
Innovative Treatment Approach
LP-310 represents a novel therapeutic strategy as an oral rinse formulation of tacrolimus (LP-10). The treatment is specifically designed to deliver localized therapeutic effects while minimizing systemic exposure, addressing a key concern in long-term treatment approaches.
"Receiving FDA approval for expanded use of LP-310 represents a key milestone in our mission to address the significant unmet need in oral lichen planus treatment," stated Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. "With no approved therapies currently available, this approval strengthens our commitment to advancing LP-310 as a potential solution for patients living with this painful and often debilitating condition."
Clinical Development Status
A Phase 2a multicenter, dose-ranging clinical trial is currently underway across seven U.S. sites. The study is evaluating three dose levels of tacrolimus (0.25 mg, 0.5 mg, and 1.0 mg) to assess the safety, tolerability, and efficacy of LP-310 in adult participants with symptomatic OLP.
Expanded Access Program Significance
The FDA's approval of the Expanded Access Program allows patients with serious or life-threatening conditions to access LP-310 outside of clinical trials before it receives full FDA approval. This program particularly benefits patients who have exhausted other treatment options and cannot participate in clinical trials.
Market Impact
The announcement has generated significant market interest, with Lipella Pharmaceuticals' stock showing notable movement. The company's shares increased by more than 90 percent in pre-market trading, reflecting investor confidence in LP-310's potential as a therapeutic option.
