The Food and Drug Administration (FDA) has approved Sinuva (mometasone furoate; Intersect ENT) Sinus Implant, a new option for the treatment of recurrent nasal polyp disease in patients aged ≥18 years who have had previous ethmoid sinus surgery.
Once implanted, Sinuva expands into the sinus cavity and delivers the drug directly to the site of polyp disease for 90 days. The FDA approval was based on data from clinical studies of 400 patients, including the RESOLVE II study. In this study, the co-primary efficacy endpoints were met, which included a 63% statistically significant relative reduction in bilateral polyp grade for patients who were given Sinuva compared to control (P=0.007), as well as a reduction from baseline Nasal Obstruction/Congestion score (P=0.007).
Secondary endpoints included the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal congestion, and percent ethmoid sinus obstruction; these endpoints were achieved with statistical significance.
Mometasone furoate is a corticosteroid with potent anti-inflammatory activity. Corticosteroids have been shown to have a wide range of effects on multiple cell types and mediators involved in inflammation.
“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,” stated Robert C. Kern, MD, Chairman of Otolaryngology – Head and Neck Surgery at Northwestern University Feinberg School of Medicine.
Sinuva can be implanted during a routine physician visit. The product is anticipated to launch in the second quarter of 2018.
For more information call (866) 531-6004 or visit Sinuva.com.