PRINCETON, N.J., June 7, 2017 /PRNewswire/ -- Promius Pharma LLC announced today that its Phase 2 study of DFN-02, a novel intranasal migraine treatment under clinical development for the acute treatment of adults with migraine with or without aura, met its primary endpoint.
In this multicenter, double-blind study (Clinicaltrials.gov # NCT02856802), episodic migraine patients were randomized to receive either DFN-02 or placebo to treat a migraine attack with a moderate or severe pain level. The primary endpoint was the proportion of subjects with migraine pain freedom at 2 hours postdose (2hPF).
There was a significantly higher proportion of subjects who experienced 2hPF with DFN-02 compared with placebo: 43.8% (n=48) versus 22.5% (n=40), P<0.05. DFN-02 was also significantly better than placebo at alleviating the patients' most bothersome symptom (MBS), including nausea, photophobia, and phonophobia (70.7% versus 39.5% MBS free at 2h postdose; P<0.01). DFN-02 was well tolerated, with only 5 of 50 subjects reporting a mild or moderate adverse event.
"The positive data from this Phase 2 study indicate promise for DFN-02," said Anil Namboodiripad, PhD, Senior Vice President, Proprietary Products and President, Promius Pharma. "Scientific research, like this study, is essential to addressing the unmet needs of migraine patients."
"Patients need multiple forms of treatment to deal with episodic variability of migraine attacks," says Dr Merle Diamond, President and Managing Director of the Diamond Headache Clinic, who did not participate in this study. "DFN-02 Phase 2 results suggest that it may become a welcome option for migraine sufferers."
Additional data from the DFN-02 studies are being submitted for presentation at the International Headache Conference to be held in Vancouver in September 2017.
DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). 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 is being developed for the acute treatment of migraine with or without aura.
About Promius Pharma LLC
Promius Pharma is a wholly owned subsidiary of Dr. Reddy's Laboratories, one of the largest and most respected pharmaceutical companies in the world. With a robust commercial infrastructure and extensive research and development capabilities through its parent company, Promius Pharma is committed to bringing new products to market that meet patients' needs in dermatology and neurology. For more information, visit www.promiuspharma.com.
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SOURCE Promius Pharma LLC