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Merck stops migraine drug trial

US company pulls the plug on development of novel migraine drug following liver test abnormalities

Merck is discontinuing the clinical development of its investigational CGRP receptor antagonist, MK-3207 after pharmacological studies showed delayed asymptomatic liver test abnormalities.

While some efficacy was seen in a phase II study, as a result of the outcomes of extended phase I clinical studies, the US company has decided not to begin confirmatory phase IIb/III trials.

"Merck believes that the blocking of CGRP receptors remains an exciting pathway to address the underlying pathophysiology of migraine," said David Michelson, MD, vice president of clinical neurosciences, Merck Research Laboratories. "We are continuing our efforts to offer patients a new treatment approach."

Separately, Merck is reviewing available clinical data for its novel oral CGRP antagonist, telcagepant, which is currently in phase III trials, ahead of planned discussions with regulatory agencies later this year.

In a long-term, randomised, double-blind clinical trial, the safety and tolerability of telcagepant for the acute treatment of migraine with and without aura was assessed in patients who took either 280mg telcagepant tablets, bioequivalent 300mg oral soft elastic telcagepant capsule, or rizatriptan 10mg. The primary endpoint of the study was the proportion of patients with at least one pre-specified adverse event (chest pain, chest tightness, asthenia, paraesthesia, dysaesthesia or hyperaesthesia). Patients intermittently treated up to eight acute migraine attacks per month for a period of up to 18 months. An average of 31 and 35 attacks were treated with telcagepant and rizatriptan, respectively.

Significantly fewer patients treated with telcagepant reported at least one pre-specified adverse event compared with those treated with rizatriptan (5.0 per cent vs. 11.2 per cent; p<0.001). The most common clinical adverse events (reported with a frequency of greater than 3 per cent in either treatment group) included dry mouth, somnolence, nausea, dizziness, fatigue, nasopharyngitis, vomiting, upper abdominal pain, diarrhoea, upper respiratory tract infection, asthenia and paraesthesia. 

Migraine affects approximately 28 million Americans, primarily women. Unlike a bad headache, migraines are characterised by attacks of intense, usually one-sided, throbbing head pain that can last from four to 72 hours. The pain associated with migraine is frequently accompanied by other symptoms, including nausea, vomiting and increased sensitivity to light and sound.

10th September 2009

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