The FDA has approved Promius Pharma’s Tosymra sumatriptan nasal spray (formerly known as DFN-02) for the treatment of migraine, Promius parent company Dr. Reddy’s has announced. The company submitted an NDA for the nasal spray in April 2018.
Dr. Reddy’s Laboratories Co-Chairman and CEO G.V. Prasad commented, “We are excited about the approval of Tosymra. This approval affirms our ability to develop well-differentiated products to meet the unmet needs of patients with migraine and HCPs treating them.”
Promius Pharma President Anil Namboodiripad added, “Tosymra nasal spray is formulated using a proprietary novel excipient known as Intravail to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action. Independent research shows that 26% to 40% of migraine patients are not optimally controlled with their current treatment. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. At Promius, we are committed to developing new ways of improving patient experiences. Tosymra is a mist-like nasal spray that acts rapidly and is well tolerated.”
Read the Dr. Reddy’s press release.
