Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery.
The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid directly to the site of the polyp disease for 90 days.
“For more than a decade Intersect ENT has been focused on developing innovative therapies for chronic sinusitis sufferers. We are pleased that the approval of Sinuva will give patients with recurrent nasal polyps a new option. This FDA approval – our fourth commercial product, and our first product to be regulated as a pharmaceutical – is an exciting milestone for our team. We look forward to introducing Sinuva to physicians across the country in the coming months as we work toward our second-quarter launch,” prez & CEO Lisa Earnhardt said in a press release.
Approval came supported by clinical trial results from a study of 400 patients, including the company’s pivotal Resolve II trial. The pivotal trial reportedly met its co-primary efficacy endpoints, including a statistically significant reduction from baseline in bilateral polyp grade and reduction from baseline nasal obstruction/congestion scores.
Secondary endpoints which hit statistical significance at 90 days included the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, nasal congestion sense and percent ethmoid sinus obstruction, the company said.
Data from a randomized clinical trial of the device indicated a 63% relative reduction in bilateral polyp grade in patients treated with the device when compared to the control group.
“Sinuva represents a much-needed breakthrough for the many nasal polyp sufferers who are seeking an effective treatment. For many patients struggling to manage this disease, the current treatment approaches of repeat surgeries and high-dose oral steroids have significant limitations, and intranasal sprays and rinses rely heavily on patient compliance. I look forward to offering Sinuva to my patients,” co-principal investigator Dr. Robert Kern of the Northwestern University Feinberg School of Medicine said in a prepared statement.
In early November, Intersect ENT said that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant.