MAP's Tempo migraine drug sees strong Ph II data

The USA's MAP Pharmaceuticals says that its candidate migraine treatment met its primary endpoints in a Phase II clinical program consisting of two separate trials. The agent, which uses MAP's proprietary Tempo inhaler to provide a fast onset of action for the proven migraine drug dihydroergotamine, demonstrated clinically-significant results in a randomized, outpatient, placebo-controlled study at nine US headache centers. In addition, a second Phase II trial indicated that Tempo was well-tolerated by subjects with impaired pulmonary function.

In the first study, Tempo Migraine showed statistically-significant pain relief at two hours and sustained pain relief at 24 hours compared to placebo. In addition, it demonstrated statistically-significant pain relief at 10 minutes. While this study was powered on pain relief, it showed clinically-significant trends in the resolution of phonophobia, photophobia and nausea, reaching statistical significance at certain timepoints, the firm noted.

MAP added that no statistically significant drug-related increase in nausea was observed. Furthermore, Tempo Migraine demonstrated statistically-significant total migraine relief (from a composite score of the four main symptoms of migraine) versus placebo at 60 minutes and sustained relief at 24 hours for subjects receiving treatment. Tempo Migraine was also shown in the study to be well tolerated, with no serious adverse effects reported, including cardiovascular or respiratory adverse events. MAP noted that the effective dose it found in these Phase II studies will be investigated in a pivotal Phase III trial after discussions with the US Food and Drug Administration at its scheduled end of Phase II meeting.