Lipella Pharma Gets FDA Nod for Expanded Access of LP-310 Oral Rinse

Lipella Pharmaceuticals Inc, a clinical-stage biotechnology company focused on developing innovative therapies by reformulating active agents in existing generic drugs, announced that the US Food and Drug Administration has granted approval for an expanded access program (EAP) for LP-310, an oral rinse formulation designed to treat oral lichen planus.

LP-310 is an innovative, localized therapy formulated to provide targeted relief for oral lichen planus patients while minimizing systemic exposure. Oral lichen planus is a chronic inflammatory condition affecting the mucous membranes inside the mouth, often causing burning pain, white patches, swollen tissue and open sores. The condition impacts approximately 6 million Americans and currently has no US FDA-approved therapies.

Expanded Access Programmes allow patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the US FDA.

“Receiving US 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,” said Michael Chancellor, co-founder and CMO of Lipella Pharmaceuticals. “We are pleased to make LP-310 available to patients beyond our phase 2a clinical trial through this expanded access programme. 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.”

The US FDA’s approval for expanded use reinforces LP-310’s potential as a new therapeutic option for OLP and supports ongoing clinical development efforts.

LP-310 is an oral rinse formulation of LP-10 (tacrolimus) developed to target inflammation and immune response in oral lichen planus patients. Designed for localized therapeutic effects, LP-310 minimizes systemic exposure, reducing the risks associated with long-term steroid use. A phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic oral lichen planus. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active US sites, which are now recruiting participants.

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