Dr. Reddy’s subsidiary Promius Pharma has submitted an NDA for its DFN-02 intranasal sumatriptan for the treatment of migraine headaches, the company said.
The DFN-02 formulation includes Aegis Therapeutics’ Intravail absorption enhancer; Aegis received a US patent for formulations of triptans including Intravail in 2012.
In June 2016, Promius announced that a Phase 2 study of DFN-02 in 107 migraine patients demonstrated significantly better reduction in pain and other migraine symptoms such as nausea, light sensitivity, and noise sensitivity than placebo.
Promius Pharma President Anil Namboodiripad commented, “The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment. 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.”
Read the Dr. Reddy’s press release.
