The FDA recently approved the therapy after showing reduction in patients' polyp grade, and reduction in sense of nasal obstruction and congestion.
A new approach to recurrent nasal polyp disease in patients who have had ethmoid sinus surgery is coming to the market.
Last month, the US Food and Drug Administration (FDA) approved the SINUVA (mometasone furoate) Sinus Implant to treat the inflammatory growth nasal polyps that line nasal passages or sinuses. Polyps can cause nasal congestion, infections, and loss of sense of smell.
The mometasone furoate implant is administered into the patient’s sinus cavity. From there, it delivers an anti-inflammatory steroid directly to the site of the disease for approximately 90 days.
Susan Stimson, General Manager of SINUVA for manufacturing company Intersect ENT, told MD Magazine the sinus implant essentially serves a dual function in patients.
“Once placed into the sinus, it props open the cavity and allows for drainage,” Stimson said. “It remains in cavity to deliver anti-inflammatory medication for over 90 days.”
The sinus implant’s application to the FDA included the results of clinical studies of about 400 patients. One study (RESOLVE II) featured 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery due to recurrent symptoms and inflammation.
Patients were randomized 1:1 to either receive the treatment implant or a control procedure. The mometasone furoate patient group achieved both primary efficacy endpoints: reduction in polyp grade, and reduction in sense of nasal obstruction and congestion. Both endpoints were met at a statistically significant difference (p = 0.007).
Robert Kern, MD, Chair of Otolaryngology - Head and Neck Surgery at Northwestern Medical Center, said the results suggest the therapy has the potential to improve patient quality of life (QOL) while helping patients avoid additional surgery procedures.
“The RESOLVE II study outcomes are compelling, and the medical community is eager to embrace new treatment options such as this less invasive procedure that can easily be performed in a physician’s office,” Kern said.
Stimson emphasized to MD Magazine that the therapy is a “tremendous advancement” for patients with previous sinus surgeries, with the ability to dramatically improve QOL while deviating from the common therapies of recurrent surgeries or steroids.
She noted that one patient administered therapy during the clinical phase was a sommelier — before her condition affected her ability to smell or taste. Following the implant therapy, she was able to return to her work.
“Intersects’ focus remains on improving the quality of life for patients with ears, nose, and throat conditions,” Stimson said.
Approximately 635,000 people in the US have had previous sinus surgery and continue to visit ear-nose-throat specialists for treatment of recurring symptoms, according to Intersect ENT.
This FDA approval for Intersect ENT, its fourth approved commercial product, is its first in pharmaceutical regulation. Future products are in the pipeline, Stimson said, adding that Intersect ENT is now a combination company.
“This opens up many more opportunities in both of those grounds,” Stimson said.