BRIEF—Dr Reddy's files NDA for its migraine candidate

India’s Dr Reddy’s Laboratories has announced the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the US Food and Drug Administration.

DFN-02 is a novel intranasal spray formulation currently patented in 11 countries (total of 13 issued patents) composed of sumatriptan 10mg and Aegis Therapeutics permeation-enhancing technology known as Intravail.

According to Dr Anil Namboodiripad, senior vice president, proprietary products and president of US subsidiary 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,” explains Dr Namboodiripad. “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.”

Upon approval, the product will be commercialized by Promius Pharma.