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HomeIntersect ENTIntersect ENT Announces PDUFA Date for Office-Based SINUVA™ Steroid Releasing Sinus Implant

Intersect ENT Announces PDUFA Date for Office-Based SINUVA™ Steroid Releasing Sinus Implant

Lisa Earnhardt, president and CEO of Intersect ENT, “The SINUVA implant offers the potential to provide a less invasive and more cost-effective solution, performed easily in the doctor’s office, for patients suffering from persistent chronic sinusitis.  She went on to say, “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.”

Intersect ENT, Inc. (NASDAQ:XENT), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the company’s investigational SINUVA™ Steroid Releasing Sinus Implant and set a PDUFA target action date of January 7, 2018.

The company states that the SINUVA implant, previously known as the RESOLVE product, is placed during a routine physician office visit. The implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps, that might otherwise warrant a repeat surgical procedure. More than 635,000 Americans are potential candidates for the SINUVA implant – an underserved population, as current treatment relies on high-dose oral steroids and repeat surgery.

Lisa Earnhardt, president and CEO of Intersect ENT, “The SINUVA implant offers the potential to provide a less invasive and more cost-effective solution, performed easily in the doctor’s office, for patients suffering from persistent chronic sinusitis.  She went on to say, “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.”

SINUVA, Intersect ENT’s fourth steroid releasing implant, was evaluated in four clinical studies to assess the safety and effectiveness of the product. The randomized, blinded, multi-center phase III RESOLVE II pivotal trial evaluated 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation. Patients were randomized to one of two groups: a treatment group consisting of bilateral SINUVA implant placement in the office, or a control group consisting of a sham procedure; both groups continued to receive standard treatments such as topical nasal steroid sprays.

The trial met both co-primary efficacy endpoints, demonstrating a statistically significant reduction in nasal congestion and polyp burden. Secondary endpoints achieving statistical significance through day 90 included a reduction in the proportion of patients still indicated for repeat sinus surgery, reduction in ethmoid sinus obstruction, and improvements in both nasal obstruction symptoms and sense of smell.

 

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