Dr. Reddy’s Laboratories and its subsidiary, Promius Pharma, LLC on January 28 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 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,''the company said. “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,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories.

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 pc to 40 pc 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.”

TOSYMRA can cause serious side effects, including: heart attack and other heart problems, which may lead to death. Stop using TOSYMRA and get emergency medical help right away if you have any of the following symptoms of a heart attack, discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw.

Acute pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort,breaking out in a cold sweat, nausea or vomiting,feeling lightheaded. 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. The most common side effects of TOSYMRA include tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.