Tosymra Approved for the Acute Treatment of Migraine

The Food and Drug Administration has approved Tosymra for the acute treatment of migraines with or without aura in adults.

The Food and Drug Administration has approved Tosymra (sumatriptan nasal spray; Promius Pharma) for the acute treatment of migraines with or without aura in adults.

Tosymra is an intranasal spray containing sumatriptan 10mg, a selective 5-HT1B/1D receptor agonist. The spray contains a permeation-enhancing excipient (Intravail), which allows the product to be quickly absorbed into the systemic circulation while demonstrating a similar pharmacokinetic profile as subcutaneous (SC) sumatriptan.

In a multicenter, double-blind, randomized, placebo-controlled study, Tosymra was found to be safe, effective and well-tolerated in the acute treatment of episodic migraine.

As with other sumatriptan products, Tosymra is contraindicated in patients with: a history of coronary artery disease or coronary artery vasospasm; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; or severe hepatic impairment.

The Company stated they are currently working toward commercialization of the product.

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For more information visit promiuspharma.com.