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12:00 AM
 | 
Oct 08, 2007
 |  BioCentury  |  Regulation

Significant isn't meaningful

Despite meeting the primary endpoints in two Phase III trials, last week Frova frovatriptan was deemed not approvable to prevent menstrual migraine. In yet another sign that FDA is moving the goalposts on product approvals, Vernalis plc and partner Endo Pharmaceuticals Holdings Inc. said the agency questioned whether the benefit was "clinically meaningful."

The trial protocols did not prespecify the magnitude of a treatment difference that might be deemed "clinically meaningful," according to Stephen Silberstein, principal investigator on the first pivotal study and director of the headache center in the department of neurology at Thomas Jefferson University Hospital.

"All of a sudden, FDA is asking someone to do something that's never been done before," he said. "They've always asked for statistical significance - never clinical meaningfulness in the past. Nobody knows what it is."

According to the most recent (2004) guidelines from the National Headache Foundation, about 60% of women who experience migraine also have menstrually related migraine (MRM), which occurs in close relationship to the onset of menstruation (e.g., from 2 days before to up to 4 days after the onset of bleeding).

MRMs differ from other migraines in that they typically last longer, are more severe, more often occur with nausea and vomiting, are more resistant to treatment and are more subject to recurrence.

Triptans are...

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