Production & Manufacturing
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Dr. Reddy’s, Promius Pharma file NDA with FDA for migraine candidate

PBR Staff Writer Published 03 April 2018

Dr. Reddy’s Laboratories and its subsidiary Promius Pharma have filed a new drug application (NDA) with the US Food and Drug Administration (USFDA) for migraine candidate DFN-02.

DFN-02 is an intranasal spray formulation made up of sumatriptan 10mg and Aegis Therapeutics’ permeation-enhancing technology Intravail.

The drug had shown its ability to treat pain and associated symptoms effectively during a migraine attack and also in decreasing attack-related functional disability during a randomized, placebo controlled phase 2 study in 107 subjects.

India-based Dr. Reddy’s said that data from the multicenter, double-blind trial revealed that 43.8% of the subjects had experienced freedom from pain for two hours with DFN-02 compared to 22.5% in the placebo arm.

Also, DFN-02 scored significantly better than placebo at easing most of the patient’s bothersome symptom (MBS) such as nausea, photophobia, and phonophobia.

The intranasal spray was also found to be well tolerated during the trial, said Dr. Reddy’s.

Promius Pharma proprietary products and president senior vice president Anil 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.”

According to Dr. Reddy’s, DFN-02 is being developed for the acute treatment of migraine with or without aura and its formulation enables sumatriptan to be quickly absorbed into the systemic circulation. The company claimed that its investigational intranasal formulation has shown pharmacokinetics that is comparable to subcutaneously administered sumatriptan.

Dr. Reddy’s had launched Promius Pharma in 2008 as its US specialty business. Located in Bridgewater, New Jersey, Promius Pharma started with mainly dermatological products along with a pipeline of topical products.

Currently, Promius Pharma has six products in its migraine pipeline including DFN-02 as listed on its website. It is also developing treatments for conditions like Acne Vulgaris, Actinic Keratosis, Epilepsy, and Plaque Psoriasis among others.