Pharma

Nasal drug delivery treatment for polyps begins enrollment for Phase 3 trials

A few months after licensing its drug delivery platform for migraine treatment to Avanir Pharmaceuticals, OptiNose is shifting its focus to nasal polyposis. The condition affects up to 4 percent of the population — about 12 million people — and produces polyps in the nasal cavity, which can impact quality of life. It has begun […]

A few months after licensing its drug delivery platform for migraine treatment to Avanir Pharmaceuticals, OptiNose is shifting its focus to nasal polyposis. The condition affects up to 4 percent of the population — about 12 million people — and produces polyps in the nasal cavity, which can impact quality of life. It has begun enrolling for the first of two Phase 3 clinical trials.

The Yardley, Pa., company’s breathable treatment for nasal polyps uses fluticasone, a topical corticosteroid. Its life science innovation is designed to prevent and reduce inflammation that accompanies the polyps by better distributing the drug through the nasal cavity.

The randomized, double-blind, studies in several centers around the world will assess patients with bilateral nasal polyposis for 16 weeks. Then, it will do an eight-week, open-label extension phase to assess safety. The two trials will assess the efficacy and safety of its drug OPN-375 using three different doses twice a day.

The company is using the trials to determine whether the treatment can reduce nasal congestion and obstruction symptoms and reduce the size of the polyps. Each study will enroll approximately 320 patients. Subsequent Phase 3 trials will include 1,500 patients.