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news.A new drug application (NDA) was submitted on 27 January 2014 to the US Food and Drug Administration for AVP-825, a product using OptiNose's innovative closed-palate Breath Powered intranasal delivery system to deliver low-dose sumatriptan powder for the acute treatment of migraine.
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The NDA submission is based on a series of laboratory and clinical studies conducted by OptiNose in the US and Europe, including comparative bioavailability and phase II and phase III efficacy studies in patients with migraine.
The NDA for AVP-825 is being submitted under 505(b)(2) regulations, and the product will be commercialized by Avanir Pharmaceuticals, a licensing partner.
OptiNose CEO Peter Miller noted the company is proud of this significant milestone for AVP-825 and for the OptiNose Breath Powered delivery technology.
"This is the first regulatory submission of a product utilizing our breakthrough drug delivery technology, highlighting the ability of OptiNose to bring important new products successfully through the development process.
"The OptiNose technology platform can be applied to a variety of liquid and powder medicines to treat both local and systemic diseases, and offers a unique solution to inherent problems with tablet, injection, and nasal spray drug delivery. We are developing a pipeline of additional products taking advantage of this new technology to improve treatment of other diseases," Miller added.
OptiNose’s closed-palate Breath Powered delivery technology is unique in that it uses the natural function of a user’s breath to propel medications beyond the nasal valve into the deep, targeted areas of the nasal cavity more effectively and efficiently than current treatment approaches.
A user exhales into the device, creating a naturally balanced closure of the soft palate and sealing off the nasal cavity completely. The exhaled breath carries medication from the device into one side of the nose through a specially shaped sealing nosepiece.
Narrow nasal passages are gently expanded and medication is transported well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air flows around to the opposite side of the nasal cavity and exits through the other side of the nose rather than into the throat or lungs.
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing closed-palate Breath Powered delivery technology.
If approved, AVP-825 would be the first and only fast-acting, dry powder intranasal form of sumatriptan for the treatment of migraine.
OptiNose is a drug delivery company developing a breakthrough closed-palate Breath Powered intranasal drug delivery technology set to transform the static nasal drug delivery market.
OptiNose has created single and multi-use nasal devices for delivering both liquid and powder formulations. The strongly patent-protected technology has been successfully tested in a number of clinical trials evaluating the advantages of the new technology.
OptiNose is developing a pipeline of products using the new technology, which is also available to license for delivery of proprietary medicines. Additional clinical programs are currently underway for the treatment of nasal polyps and for autism spectrum disorders.