Promius’s sumatriptan meets primary endpoint for migraine - Clinical Trials Arena
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Promius’s sumatriptan meets primary endpoint for migraine

16 Nov 2017

Dr. Reddy’s Laboratories’ subsidiary Promius Pharma has reported positive results from the clinical trial of its ZEMBRACE SymTouch (sumatriptan injection) to treat acute migraine headache.

Dr. Reddy’s Laboratories’ subsidiary Promius Pharma has reported positive results from the clinical trial of its ZEMBRACE SymTouch (sumatriptan injection) to treat acute migraine headache.

EMBRACE SymTouch is a prescription medicine indicated for the treatment of acute headaches with or without aura.

With 268 subjects, the multi-centre, placebo-controlled trial saw 3mg ZEMBRACE SymTouch meet both its primary and various secondary endpoints.

The investigational candidate reduced migraine pain in a high proportion of subjects at two hours after dosing.

“Physicians can consider this low-dose 3mg injectable sumatriptan as an effective treatment option for their migraine patients.”

During the trial, ZEMBRACE SymTouch was found to be well-tolerated, with 33.3% of the participants experiencing treatment-emergent adverse events (TEAE) compared to 13.4% with placebo.

Triptan-related TEAEs were observed in 7.2% of patients within two hours post-dose and the results indicated no treatment-emergent serious adverse events (SAE).

Study author and Baptist Medical Group headache clinic director Stephen Landy said: “This multi-centre, randomised, double-blind, placebo-controlled trial demonstrates that the 3mg dose of sumatriptan in ZEMBRACE SymTouch provided rapid, complete pain relief in a significant proportion of patients with a low rate of side effects and no SAEs.

“Physicians can consider this low-dose 3mg injectable sumatriptan as an effective treatment option for their migraine patients.”