Drug-Delivery Patch Shows Promise for an Overlooked Disease

A biodegradable drug-delivery patch met the primary and multiple secondary endpoints in a phase 2b study in patients with oral lichen planus (OLP), a chronic inflammatory condition characterized by lesions and ulcers inside the mouth. According to AFYX Therapeutics, the study is the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients. The 20 μg dose Rivelin clobetasol patch (Rivelin-CLO) demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of four weeks, the Copenhagen, Denmark-based company said. Secondary endpoints focused on capturing patient symptomatic improvement also demonstrated statistical significance, AFYX said. The company also noted that no serious adverse events were observed and patients reported overall ease of use and patch adherence to the oral cavity for an average of 90 minutes. The study was conducted in Europe and North America, "We are excited by the results of this phase 2b study of Rivelin-CLO, which clearly demonstrated first-of-its kind therapeutic benefit for patients with OLP, a condition for which no approved therapies exist," said Nishan de Silva, MD, CEO of AFYX Therapeutics. "Investigators we have been working with have expressed challenges with existing treatment options – topical treatments, ointments, and mouth rinses that don't provide adequate results â...
Source: MDDI - Category: Medical Devices Authors: Tags: R & D Source Type: news