4 April 2018 - - Hyderabad, India-based integrated pharmaceutical company Dr. Reddy's Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and its subsidiary, US-based healthcare solutions company Promius Pharma LLC, have filed a new drug application (NDA) with the US Food and Drug Administration for its migraine candidate DFN-02, the company said.
In a multicenter, double-blind, randomised, placebo controlled study with 107 subjects, DFN-02 demonstrated that it can effectively treat pain and associated symptoms during a migraine attack and reduce attack-related functional disability.
Data from this study show that there was a significantly higher proportion of subjects who experienced 2-hour pain freedom with DFN-02 compared with placebo: 43.8% versus 22.5%. DFN-02 was also significantly better than placebo at alleviating the patients' most bothersome symptoms, and was well tolerated, with mild to moderate treatment-emergent adverse events.
Upon approval, the product will be commercialized by Promius Pharma.
DFN-02, a novel intranasal spray formulation composed of sumatriptan 10 mg and Aegis Therapeutics, LLC permeation-enhancing technology known as Intravail, is in development for the acute treatment of migraine with or without aura.
This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan.
Dr. Reddy's is committed to providing affordable and innovative medicines through its three businesses - pharmaceutical services and active ingredients, global generics, and proprietary products.
The company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe, including the US, India, Russia and CIS countries, and Europe.