According to Avanir Pharmaceuticals, the company has submitted a 505(b)(2) New Drug Application (NDA) for its AVP-825 intranasal dry powder sumatriptan for the treatment of migraine to the FDA. Avanir acquired the North American license for the product from OptiNose in July 2013.
The product uses OptiNose’s delivery device, which uses the patient’s breath to aerosolize the powder and transport the drug into the nasal cavity. In September 2013, Avanir published data from a PK study showing faster rise in plasma concentration for the dry powder intranasal formulation than for a conventional sumatriptan nasal spray.
Avanir Chief Scientific Officer Joao Siffert said, “The AVP-825 NDA submission represents an important milestone for Avanir. If approved by the FDA, AVP-825 could meet a key unmet need by providing patients with a unique device that efficiently delivers a low dose of sumatriptan powder, providing rapid relief of migraine headache, coupled with good tolerability.”
Read the Avanir press release.
