Beginning a large two-part Phase III study, OptiNose enrolled the first of over 600 patients to evaluate its double-barreled fluticasone inhaler designed to treat nasal polyps.
The device uses OptiNose's so-called Breath Powered delivery system, which employs both a mouthpiece and a nosepiece; the user exhales into the mouthpiece to propel medication into the nasal cavity. According to the company, the natural breathing action closes the soft palate to seal off the nasal cavity for more targeted delivery of sinus medication.
The two studies, called NAVIGATE I and II, will each enroll about 320 patients, the company said, and will test the fluticasone compound OPN-375 in three doses--100 µg, 200 µg and 400 µg--twice a day. The two different endpoints will address the congestion aspect of the condition and the actual size of the polyps over the four-month study, which will be followed by a two-month safety assessment.
For nasal polyps in particular, which are growths on the nasal cavity lining that often require surgery, the corticosteroid fluticasone is both a preventive measure and an inflammation reducer. With the dual-action delivery system, the medication is able to more fully bathe the area.
"Existing methods for treating nasal polyps are limited, and there is a need for improved and alternative options," the studies' lead investigator, Dr. Donald Leopold, said in a statement. "The nasal cavity is complex, making it hard to deliver drugs to the right place. OptiNose's Breath Powered delivery system represents an innovative way to deliver fluticasone to hard-to-reach areas to treat nasal polyps."
With these studies, Pennsylvania-based OptiNose has two candidates in the late-stage clinic, the other being a sumatriptan compound for acute migraine, according to CEO Peter Miller. Altogether, including two other Phase III studies of the same drug-device combo for chronic sinusitis, the company is enrolling over 1,500 patients, he said.
Back in July, Avanir Pharmaceuticals ($AVNR) offered up to $110 million, including milestone payments, for OptiNose's migraine version of the device, which demonstrated solid results in a Phase III trial late last year.
- here's the release