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| OptiNose's delivery devices with nosepiece and mouthpiece--Courtesy of OptiNose |
Specialty pharma OptiNose hopes to use up to $30 million in new financing to get its OPN-375 in combination with its novel breath-powered liquid device through the FDA. But the agency already demonstrated some skepticism around the company's powder device last year--it issued a complete response letter to OptiNose partner Avanir because of device errors and required further testing.
Now, OptiNose is focused on its OPN-375, which is for the treatment of nasal polyposis with associated nasal congestion, in combination with its drug delivery system.
The startup expects that its OptiNose Bi-Directional Breath Powered drug delivery device could challenge traditional inhalers because it's designed to more effectively deliver medications beyond the nasal valve and deep into the nasal cavity. The user exhales into the device, which seals off the throat, and that breath carries medication into one side of the nose. Then the medication flows to the opposite side of the nasal cavity, exiting through the nose rather than traveling into the throat or lungs.
But the Avanir complete response demonstrated a concern about the ability of everyday migraine patients to use the device safely and effectively with the low-dose, intranasal powdered sumatriptan. In fact, the FDA required a new human factors validation study to assess the usability of an improved device.
Since then, Avanir has resubmitted the combo to the FDA with a PDUFA date slated for Nov. 6. The Avanir candidate, AVP-825, offered faster migraine relief than oral sumatriptan in clinical testing. Avanir is a wholly owned subsidiary of Otsuka, after the completion of a $3.5 billion acquisition earlier this year.
As for its own candidate OPN-375, OptiNose said in a statement that it has already "largely completed a successful clinical program supporting submission of an NDA."
"With this latest round of financing, we are well-positioned to make the most of our lead asset, OPN-375, as well as continue development of our pipeline products like OPN-300," said OptiNose CEO Peter Miller in a statement. "As we recently announced, our Phase III clinical program supporting the launch indication for OPN-375 produced excellent results and after a planned pre-NDA meeting we intend to submit an NDA as soon as possible." OPN-300 is a Phase II large molecule to treat serious central nervous system disorders including autism.
OptiNose was founded in 2000 and previously has raised at least $50 million according to SEC filings; its investors include Avista Capital Partners, WFD Ventures and Entrepreneurs Fund.
- here is the announcement