Sumatriptan Nasal Spray Approved for Acute Migraine Treatment

The Food and Drug Administration has approved sumatriptan nasal spray 10mg (Tosymra; Promius Pharma, Princeton, NJ) for acute treatment of migraine with or without aura in adults. This formulation of sumatriptan uses technology that allows oral, buccal, dermal, and intranasal drug delivery of nonpeptide, peptide, and protein drugs up to 30 daltons in size that previously could only be delivered via injection. 

“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 health care providers treating them,” said GV Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories, owner of Promius Pharna.

According to Dr. Anil Namboodiripad, PhD, President, Promius Pharma, “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.”