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ARTICLE | Clinical News

Promius reports Phase II data for DFN-02 in migraine

November 17, 2017 6:44 PM UTC

In September, the Promius Pharma LLC subsidiary of Dr. Reddy's Laboratories Ltd. (NYSE:RDY) reported data from a Phase II trial in 107 patients with episodic migraine showing that intranasal DFN-02 significantly increased the proportion of patients with migraine pain freedom at 2 hours post-dose vs. placebo. Specifically, DFN-02 led to migraine pain freedom at 2 hours, the primary endpoint, in 43.8% of patients vs. 22.5% for placebo (p<0.05). DFN-02 also alleviated patients’ most bothersome symptom at 2 hours post-dose in 70.7% of patients vs. 39.5% for placebo (p<0.01). Additionally, DFN-02 significantly increased the proportion of patients who were pain free from 2-24 hours (38.9% vs. 13.8%, p=0.029), nausea free at 2 hours post-dose (78.3% vs. 42.1%, p=0.026), photophobia free at 2 hours post-dose (71.8% vs. 38.9%, p=0.005) and phonophobia free at 2 hours post-dose (78.1% vs. 40%, p=.004) vs. placebo.

DFN-02 also led to a greater reduction in functional disability at 2 hours post-dose vs. placebo (1.2 vs. 0.6 points on a 4-point scale, p<0.001), a higher overall satisfaction at 2 and 24 hours post-dose on Patient Perception of Migraine Questionnaire-Revised (PPMQ-R) total score vs. placebo (p=0.003 and p=0.016, respectively) and higher satisfaction at 24 hours post-dose on PPMQ-R total score compared to baseline on their usual migraine medication (p=0.012). Additionally, DFN-02 increased the proportion of patients who had sustained headache pain freedom at 2-24 hours (38.9% vs. 13.8%, p=0.029) and decreased the proportion of patients who used a second dose of DFN-02 or rescue medication between 2-24 hours post-dose (12.2% vs. 48.8%, p<0.001) vs. placebo. The intranasal spray formulation of sumatriptan and a permeation-enhancing excipient was well tolerated with no serious adverse events reported...

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