Dr. Reddy’s Laboratories and Promius Pharma announced the filing of their New Drug Application (NDA) for DFN-02 (sumatriptan), a novel intranasal spray candidate for the acute treatment of migraine with or without aura.
DFN-02 is an investigational intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist. The spray utilizes Intravail technology, which allows DFN-02 to be quickly absorbed into the systemic circulation while demonstrating a similar pharmacokinetic profile as subcutaneous (SC) sumatriptan.
DFN-02 was evaluated in a multicenter, double-blind, randomized, placebo-controlled study (N=107) which showed it was effective in treating pain and associated symptoms during a migraine attack and in reducing attack-related functional disability. A significantly greater proportion of study patients experienced 2-hour pain freedom with DFN-02 vs placebo (43.8% vs 22.5%; P<0.05).
Treatment with DFN-02 also significantly alleviated the patients’ most bothersome symptom (MBS) better than placebo (70.7% vs 39.5% MBS-free at 2 hours post-dose; P<0.01); symptoms included nausea, photophobia, and phonophobia.
DFN-02 was well tolerated among study patients with dysgeusia, application site pain, chest discomfort, burning sensation, rhinorrhea, and malaise being the most common treatment-emergent adverse effects.