Optinose’s XHANCE Review Extended by FDA for Chronic Rhinosinusitis Treatment

Optinose

YARDLEY, PA — Optinose (NASDAQ: OPTN), a pharmaceutical company specializing in treatments for ear, nose, and throat conditions, recently announced an extension in the review period of its supplemental new drug application (sNDA) for XHANCE. The U.S. Food and Drug Administration (FDA) has pushed back the Prescription Drug User Fee Act (PDUFA) goal date to March 16, 2024.

On November 15, 2023, as part of the ongoing sNDA review process, the FDA requested additional efficacy subset analyses of existing clinical data from one of the trials submitted in the sNDA: ReOpen1. Optinose promptly responded to this request and submitted the required analyses on November 22, 2023.

However, on December 4, 2023, the FDA informed Optinose that it needed more time to review this submission, which it classified as a major amendment, leading to the extension of the PDUFA goal date. The additional subset analyses requested by the FDA evaluated a subgroup of patients in ReOpen1 who had no nasal polyps or had a nasal polyp grade of one or less at trial entry.

Ramy Mahmoud, MD, MPH, CEO of Optinose, highlighted the significant need for effective treatment options for chronic sinusitis. With approximately 10 million physician office visits coded annually, chronic sinusitis is a prevalent diagnosis in adult outpatient visits. However, there are currently no FDA-approved drug treatments for the majority of these patients, particularly those who do not have nasal polyps.

Dr. Mahmoud expressed optimism about the potential of XHANCE to fill this gap. He stated, “We believe the ReOpen trials demonstrated important clinical benefits XHANCE could offer chronic sinusitis patients and, if approved, we look forward to providing doctors and their patients the first-ever medication to treat all chronic sinusitis patients, including those with or without nasal polyps.”

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XHANCE is a drug-device combination product that includes a nasal spray containing fluticasone propionate, a widely used nasal anti-inflammatory drug. This drug is delivered using the innovative Exhalation Delivery System (EDS), designed to deliver medication high and deep into hard-to-reach sinuses and sinonasal drainage tracts.

For more details on the subset analyses, Optinose filed a Current Report on Form 8-K with the Securities and Exchange Commission on December 6, 2023.

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