FDA accepts sNDA for Optinose’s XHANCE
Betsy Goodfellow | May 5, 2023 | News story | Medical Communications | Ear Nose & throat, FDA, Nasal Spray, optinose, sNDA
Optinose has announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for its XHANCE (fluticasone propionate) as a treatment option for chronic rhinosinusitis.
XHANCE is a nasal spray drug-device combination product, utilising the most commonly used nasal anti-inflammatory drug with an innovative Exhalation Delivery System (EDS), designed to deliver the drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.
This sNDA submission follows data from two phase 3 clinical trials in patients with chronic sinusitis, and has been assigned a Prescription Drug User Fee Act (PDUFA) target goal date of 16 December 2023.
The trials were part of the ReOpen Program, which assessed the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily over 24 weeks in two global, randomised, double-blind, placebo-controlled phase 3 trials including patients with chronic sinusitis.
Ramy Mahmoud, MD, MPH, CEO of Optinose, commented: “Chronic sinusitis is one of the top diagnoses made in adult outpatient visits, with approximately ten million physician office visits coded annually, yet there is a high level of patient dissatisfaction and suffering and no FDA approved drug treatments except for patients who also have nasal polyps. We are excited to see our study data under FDA review as we believe the ReOpen trials found important benefits that XHANCE could offer to physicians and their patients as a first-ever drug approved to treat chronic rhinosinusitis.”
Betsy Goodfellow
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