Dr. Reddy’s Files NDA for Migraine Treatment

Dr. Reddys

Migraine sufferers could have a new treatment option. India-based Dr. Reddy's Laboratories and its subsidiary Promius Pharma, LLC filed a New Drug Application with the U.S. Food and Drug Administration for approval of migraine candidate DFN-02.

Dr. Reddy’s DFN-02 is a novel intranasal spray formulation of 10 mg of sumatriptan. The medication uses Aegis Therapeutics permeation-enhancing technology Intravail to more effectively deliver the medication. This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan. DFN-02 has been developed for the acute treatment of migraine headache with or without aura.

Anil Namboodiripad, president of New Jersey-based Promius Pharma, said the NDA for DFN-02 is an important step forward in the company’s mission to bring solutions that address unmet needs.

“The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment,” Namboodiripad said. “Acute migraine attacks are typically associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory resolution of their migraine attack.”

Migraines impact about 12 percent of the population in the United States, including children. The pain and other symptoms associated with migraines can cause sufferers to completely stop what they are doing and prevent them from working or functioning in a normal capacity for more than a day. Migraines with aura, also called classic migraines, includes sensory disturbances such as flashes of light, tingling in hands and blind spots.

During clinical testing, Dr. Reddy’s DFN-02 demonstrated it can treat pain and migraine-associated symptoms. Additionally, the data said DFN-02 reduced attack-related functional disability in migraine headache patients.

Trial data of 107 patients showed that patients treated with DFN-02 achieved two-hours of pain freedom in 43.8 percent of patients. That was in comparison to 22.5 percent of placebo patients. DFN-02 was also significantly better than placebo at alleviating the patients’ most bothersome symptoms, which includes nausea, photophobia, and phonophobia, an anxiety disorder that results in the fear of loud sounds. Those symptoms were alleviated in 70.7 percent of dosed migraine patients, in comparison to 39.5 percent of placebo patients.

Dr. Reddy and Promius are seeking approval in an area that has seen a lot of recent movement. Earlier this year pharma giant Amgen unveiled Phase IIIb data that showed its migraine drug Aimovig is effective in treating both mean migraine days as well as reducing the number of episodic headaches in patients who have not responded to previous treatments. Teva Pharmaceuticals is expecting the U.S. Food and Drug Administration to rule on its CGRP migraine treatment fremanezumab by the end of June.

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