|By PR Newswire||
|March 27, 2014 08:30 AM EDT|
YARDLEY, Pa., March 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered™ investigational drug-device combination product for the acute treatment of migraine.
As previously reported, the 505(b)(2) NDA for AVP-825 includes clinical data developed by OptiNose including a pivotal phase III controlled clinical trial, a supportive phase II controlled clinical trial and two pharmacokinetic studies. The NDA also references data from the extensive clinical use of sumatriptan over the past 20 years.
The acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) V goal date is November 26, 2014.
About OptiNose Breath Powered™ Delivery Technology
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, chronic sinusitis and for autism spectrum disorders.
OptiNose licensed exclusive North American rights for the further development and commercialization of AVP-825 to Avanir Pharmaceuticals in July 2013. In accordance with this arrangement, OptiNose will ultimately transfer the U.S. IND for AVP-825 to Avanir, and Avanir assumed responsibility for the final filing of the U.S. NDA and for North American commercial manufacturing and sales.
Investors in OptiNose include Avista Capital Partners in New York, WFD Ventures LLC located in New York and Entrepreneurs Fund LP based in Jersey, Channel Islands. For more information please visit www.optinose.com.