FDA Issues Complete Response Letter for AVP-825 New Drug Application

YARDLEY, PA, November 26, 2014—OptiNose today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) by Avanir Pharmaceuticals for AVP-825, an investigational drug-device combination product developed by OptiNose which uses OptiNose’s patented Bi-Directional™ Breath Powered™ technology to deliver a low dose of sumatriptan powder into the nose. AVP-825 was licensed by OptiNose to Avanir Pharmaceuticals for commercialization in North America.

In the Complete Response Letter, the FDA requested that the user-interface (which includes, for example, the packaging and patient instructions for use) be modified and that a new human factors validation study be performed. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safely and effectively.

“In tandem with our partner Avanir, we believe the issue raised by the FDA is fully addressable and have already begun efforts to complete the necessary work,” said Peter Miller, Chief Executive Officer of OptiNose. “Together, we are well-positioned to rapidly address the human factor concern and plan to respond to FDA in the first half of 2015. We are extremely pleased the FDA review did not express any other concerns, including no concerns regarding the clinical or non-clinical safety or efficacy data, nor chemistry, manufacturing, and controls (CMC). We are also pleased that the FDA did not request that any additional clinical trials be conducted prior to approval. This is a tribute to the tireless efforts by our team and increases our confidence in the approval path for AVP-825. Once approved, we believe the product will be an important new treatment option for patients with migraine headaches looking for an innovative, fast acting, well-tolerated solution.”

About OptiNose’s Bi-Directional™ Breath Powered™ Delivery Technology
OptiNose’s patented closed-palate Bi-Directional 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 natural 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, balancing the pressure on the soft palate. 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.

About AVP-825
AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder delivered intranasally utilizing OptiNose’s closed-palate Bi-Directional 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. AVP-825 is an investigational drug-device combination product not approved by the FDA.

About OptiNose
OptiNose is a Specialty Pharmaceutical Company built around a unique nasal delivery technology platform. The Bi-Directional Breath Powered device platform provides dramatically enhanced delivery of drug into the nasal cavity compared to current treatments. When used to deliver select medications, the technology may enable value enhanced products with important new efficacy or safety characteristics. OptiNose has created single and multi-use devices for intranasal delivery of both liquid and powder drug formulations. The strongly patent-protected technology has been successfully tested in a number of clinical trials evaluating the advantages of this new technology. OptiNose is developing a pipeline of assets currently for the treatment of Central Nervous System disorders and Nasal Inflammatory Diseases. For more information, please visit www.optinose.com.

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.

OptiNose Media Contact
Dan Zacchei, Sloane & Company