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.
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."