A new inhaled migraine drug might stop the headache even if hours pass before the patient takes it, phase III trial data show.
Results with Levadex (MAP Pharmaceuticals), an orally inhaled form of dihydroergotamine (DHE), were presented this week at the 63rd annual meeting of the American Academy of Neurology in Honolulu.
DHE has been used intravenously for years in migraine patients. Like DHE, Levadex is long-acting and achieves a low recurrence rate, said Dr Shashidhar Kori.
Its side effects are fewer, however, and it can be given to patients with cardiovascular disease, according to Dr Kori, who is a vice-president at MAP Pharmaceuticals in Mountain View, California, the company that's developing the new drug.
In a post hoc analysis of a phase III study, Dr Kori's team analysed 2-hour pain-relief and pain-free rates in 771 patients who took Levadex or placebo at varying times after onset of a moderate or severe migraine.
Pain-relief rates for Levadex and placebo, respectively, were as follows:
- Taken within one hour of headache onset, 66% vs. 41%
- Fromone to four hours after onset, 60% vs. 35%
- From four to eight hours, 53% vs. 30%
- After eight hours, 49% vs. 24%
A similar pattern was observed for pain-free rates 2 hours after taking the study drug, for Levadex and placebo, respectively:
- Taken within one hour of pain onset, 38% vs. 13%
- Taken from one to four hours after onset, 28% vs. 10%
- From four to eight hours, 22% vs. 8%
- Beyond eight hours, 19% vs. 9%
In contrast, the effectiveness of triptan drugs - a mainstay of migraine treatment - falls off rapidly if they're not taken quickly after the headache starts, but patients can't always take them immediately.
Dr Kori noted that with intravenous DHE, 70% to 100% of patients would have nausea, whereas only 4.5% of Levadex patients had nausea. The most common adverse event in the phase III trial was medication aftertaste (6% with Levadex vs. 2% with placebo).
He said the company plans to apply for Levadex approval from the US Food and Drug Administration later this year. In the meantime, the company has already entered into an arrangement with Allergan Inc. to co-promote the drug, pending approval. (Reuters Health/ April 2011)
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