New therapy for acute treatment of migraine with or without aura received FDA approval

On January 27, 2019, Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC. announced that DFN-02 (TOSYMRA™) nasal spray had been approved for acute treatment of migraine with or without aura in adults.

The effectiveness of DFN-02 in treating pain and associated symptoms during a migraine attack was demonstrated in a Phase 2 randomized, placebo-controlled trial. The primary outcome showed that 43.8% of participants were pain-free at two hours post-dose. Additionally, treatment with the therapy significantly alleviated the most bothersome symptom—which included nausea, photophobia and phonophobia—for 70.7% of participants at two hours post-dose.

As always, the American Migraine Foundation encourages you to ask your healthcare provider about this therapy to determine whether it’s right for you. For more information about TOSYMRA™, please consult your physician and refer to the approved FDA label. For more news about migraine treatment and research, please visit our doctor-verified resource library.