Dr. Reddy's gets USFDA approval for TOSYMRA for treatment of migraine

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company is working toward commercialization of this product.

Hyderabad: Dr Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC recently announced the approval of TOSYMRA(previously known as DFN-02) by the U.S. Food and Drug Administration (FDA).

TOSYMRA is indicated for the acute treatment of a migraine with or without aura in adults. TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company is working toward commercialization of this product.

“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 a migraine and HCPs treating them,” said G.V. Prasad, Co-Chairman and CEO, Dr Reddy’s Laboratories.

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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.1 For patients who suffer from the debilitating and disruptive effects of a 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.”

However, TOSYMRA is not for people with risk factors for heart disease (high blood pressure, high cholesterol levels, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

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TOSYMRA is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

TOSYMRA is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (a rare form of migraine with aura) migraines. TOSYMRA is not used to treat cluster headaches.TOSYMRA is not used to prevent or decrease the number of migraines you have.

It is not known if TOSYMRA is safe and effective in children under 18 years of age.

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