According to Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma, the NDA for DFN-02 is an important step forward in the company's mission to bring solutions that address unmet needs.
"The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment," Namboodiripad said in a statement.
"Acute migraine attacks are typically associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory resolution of their migraine attack."
According to the Hyderabad-based firm, in a multicentre, double-blind, randomized, placebo controlled study with 107 subjects, the DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack and reduce attack-related functional disability.
Upon approval, the product will be commercialised by Promius Pharma.
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