Merck Experimental Migraine Drug Proves Better Than Zomag In Late-Stage Study

Mon. June 30, 2008; Posted: 11:00 PM

Telcagepant works through a new mechanism of action meant to avoid cardiovascular side effects, including racing heartbeat and chest pains, often seen with standard "triptan" treatments such as Zomig, GlaxoSmithKline Plc's (NYSE: GSK | Quote | Chart | News | PowerRating) Imitrex and Merck's own Maxalt.

Favorable phase 3 data for Merck's oral medicine telcagepant, formerly known as MK-974, were similar to those seen in earlier mid-stage studies. Merck plans to seek U.S. approval next year for the drug.

Merck said the trial pitted telcagepant against Zomig, rather than far-better-selling Imitrex, because the AstraZeneca drug is also considered a highly effective treatment.

The study involved 1,380 adult patients tested after experiencing a single moderate or severe migraine attack. Patients received either 150-milligram or 300-milligram doses of telcagepant, a five milligram dose of Zomig, or a placebo. The average age of patients was 43, and about 85 percent were women, in view of the fact that most migraine sufferers are female.

Effectiveness of the drugs was assessed by their ability to meet five criteria after two hours: pain relief, pain freedom, absence of sensitivity to sound, absence of sensitivity to light and absence of nausea.

Merck said that the overall effectiveness of the 300-milligram dose of telcagepant was found to be comparable to Zomig, and significantly more effective than placebo. About 55 percent of patients who received high-dose telcagepant reported reduction of pain at two hours, compared with 56 percent for Zomig and 28 percent for those taking placebos.

An estimated 27 percent of patients getting the Merck drug reported being pain-free at two hours, compared with 31 percent for Zomig and 10 percent for placebo. Telcagepant and Zomig were about equally successful in controlling sensitivity to sound and light, two hardships that often accompany migraine headaches.

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