12:00 AM
Oct 27, 2003
 |  BioCentury  |  Product Development

Nauseating problem

Pozen Inc.'s MT 300 has run up against the rocks of nausea, a side effect that has plagued other pain medications. But unlike products that have won FDA approval, the company's injectable dihydroergotamine mesylate (DHE) so far is showing significantly more nausea at two hours versus placebo, which resulted in a non-approvable letter from the agency last week.
Although nausea is a secondary endpoint, FDA requires migraine compounds to show a positive effect on it and other ancillary measures. Indeed, several approved migraine drugs reduced nausea below placebo levels in the two-hour timeframe. The differences may not have been statistically significant, but none of those products did significantly worse than placebo at that time point (see "Migraine Comparisons").

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