Dr. Reddy’s and its subsidiary, Promius Pharma announced the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the U.S. Food and Drug Administration (FDA).
“The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment,” said 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.”
In a multicenter, double-blind, randomized, placebo controlled study with 107 subjects (Clinicaltrials.gov # NCT02856802), DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack and reduce attack-related functional disability. Data from this study show that there was a significantly higher proportion of subjects who experienced 2-hour pain freedom with DFN-02 compared with placebo: 43.8% (n=48) versus 22.5% (n=40), p<.05). DFN-02 was also significantly better than placebo at alleviating the patients’ most bothersome symptom (MBS), including nausea, photophobia, and phonophobia (70.7% versus 39.5% MBS free at 2 hours postdose; p<.01. DFN-02 was well tolerated, with the following Treatment-Emergent Adverse Events: dysgeusia (n = 4), application site pain (n = 2), chest discomfort, burning sensation, rhinorrhea and malaise (n = 1 each), all mild to moderate.
Upon approval, the product will be commercialized by Promius Pharma.
DFN-02 is a novel intranasal spray formulation currently patented in 11 countries (total of 13 issued patents) composed of sumatriptan 10 mg and Aegis Therapeutics permeation-enhancing technology known as Intravail. DFN-02 is a novel investigational intranasal formulation in development for the acute treatment of migraine with or without aura. This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan.