Intersect ENT announced that their New Drug Application (NDA) for the investigational steroid-releasing sinus implant, Sinuva, has been accepted by the Food and Drug Administration (FDA) with a Prescription Drug User Fee Act date set for January 7, 2018.
The Sinuva implant releases mometasone furoate to the ethmoid sinus lining and is intended to treat chronic sinusitis patients who have recurrent sinus obstruction. If approved it would provide an alternative to revision surgery, with the implant being placed during a routine physician office visit.
The NDA includes data from four clinical studies, including the Phase 3 ‘Resolve II’ study which assessed 300 patient who were indicated for revision sinus surgery at study entry due to obstructive inflammation. Patients were randomized 1:1 to either receive a Sinuva implant or to undergo a sham procedure. Results showed that the Sinuva group had statistically significant reductions in nasal congestion and polyp burden, meeting the trial’s primary endpoint.
“We are excited that FDA’s filing of this NDA advances us a step closer to bringing this important innovation to ENT physicians and their patients,” said Lisa Earnhardt, president and CEO of Intersect ENT.
For more information visit Intersectent.com.