Merck migraine drug shows promise in clinical trial
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An experimental migraine drug being developed by Merck & Co. significantly relieved pain two hours after dosing compared to a placebo in a mid-stage clinical trial, the company said on Thursday.
The drug, MK-0974, also demonstrated sustained pain relief through 24 hours, according to data presented at the American Headache Society annual meeting in Chicago.
The medicine has already been advanced into late stage testing for acute treatment of migraine in adults. If it is eventually approved, it could become the first new class of migraine treatments on the market since 1991, Merck said.
The company said it remains on track to apply for U.S. approval of MK-0974 in 2009.
MK-0974 is an oral calcitonin gene-related peptide (CGRP) receptor antagonist that works by blocking transmission of pain signals that lead to migraine headaches. CGRP and its receptors are found in areas of the central and peripheral nervous system and are believed to be involved in transmission of migraine pain.
The 420-patient study tested the drug at three doses against a placebo and an older Merck migraine drug rizatriptan, which is sold under the brand name Maxalt.
In the primary goal of measuring pain reduction from severe or moderate to mild or none two hours after dosing, MK-0974 was statistically significantly better than placebo, researchers said.
The study was not large enough to accurately measure differences between the various doses of MK-0974 or between the experimental drug and rizatriptan, although the results were reported.
The proportion of patients reporting pain relief at two hours for those treated with MK-0974 was 68.1 percent at 300 milligrams; 48.2 percent at 400 mg; and 67.5 percent at 600 mg. There was a 69.5 percent response rate in the 34-patient rizatriptan group and 46.3 percent response for placebo.
MK-0974 was also significantly better than a placebo on secondary measures such as 24-hour sustained pain-relief and 24-hour sustained pain-freedom, researchers said.
The drug also appeared to relieve migraine-related symptoms, such as nausea and sensitivity to light and sound, although the study was not powered to evaluate a statistical response to those measures, researchers said.
“These results provide additional evidence of the potential benefit of CGRP receptor antagonists as a new and promising class of migraine therapies,” headache specialist Dr. Alan Rapoport, one of the study’s investigators, said in a statement.
Migraine headaches affect about 28 million Americans, primarily women.
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