According to intranasal drug developer OptiNose, the company has raised $37 million in a Series D financing round led by Fidelity Management and Research Company. The company said that it plans to use the money to prepare for the US launch of OPN-375 intranasal fluticasone propionate if approved.
OptiNose submitted an NDA for OPN-375 for the treatment of nasal polyposis in November 2016, and announced in January 2017 that the FDA had accepted the application. The PDUFA goal date for completion of the FDA’s review of the NDA is in September 2017.
OPN-375 is based on the company’s Breath Powered delivery system which is designed to deliver the drug deep in the nasal cavity.
OptiNose CEO Peter Miller said, “We are building a company dedicated to meeting the needs of patients treated by ENT/allergy specialists and using our patented technology and other approaches to create innovative products that improve clinical outcomes and make lives better. Chronic rhinosinusitis (CRS) with or without nasal polyps, our current focus, is a large market worldwide. Data suggest there is tremendous dissatisfaction with the current medical treatment options.”
Company President and COO Ramy Mahmoud added, “This is a serious disease, and it causes a high degree of suffering for millions of people in the US alone. OPN-375 could fill an important role in the care pathway for the many patients who do not get satisfactory relief with current treatments. We have an excellent team that is eager to make this product available to patients, and this latest round of funding will put us in a position to make the investments needed to ensure that, if approved, we are ready for launch in the first half of 2018.”
Read the OptiNose press release.
