MSD publishes strong migraine trial results

Merck, Sharp & Dohme, the UK subsidiary of US drug major Merck & Co, has published the results of a Phase III trial demonstrating that telcagepant, an investigational oral calcitonin gene-related peptide receptor antagonist, significantly improved relief of migraine pain and associated symptoms versus placebo and was comparable to Anglo-Swedish drug major AstraZeneca's Zomig (zolmitriptan), but had a lower incidence of adverse events.

The study, published in The Lancet, reports on results from a randomized, double-blind, placebo- and active-controlled Phase III trial in patients with migraine. A total of 1,380 adult subjects who experienced a single moderate or severe migraine attack were treated with either telcagepant (as a liquid-filled soft gel capsule) at doses of 150mg or 300mg, zolmitriptan 5mg or placebo. Patients from Europe and the USA who enrolled were primarily women (85%), with an average age of 42 years.

Overall treatment effect was assessed by analysing five primary endpoints at two hours post-dose: pain relief (reduction to mild or none); pain freedom (reduction to no pain); absence of sensitivity to sound (phonophobia); absence of sensitivity to light (photophobia); and absence of nausea. The treatment effect of the 300mg dose of telcagepant was significantly greater than placebo for all five primary endpoints in the study (p=<0.01 for freedom from nausea and p<0.001 for all others) and comparable to zolmitriptan. Telcagepant 150mg was found to be nominally significant compared to placebo for all five primary endpoints (p<0.005) although a statistically-significant positive result cannot be formally claimed, according to the firm.