14 April 2011

Inhaled migraine drug effective so far

A new inhaled migraine drug might stop the headache even if hours pass before the patient takes it, initial results have shown.


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.

Side effects

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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Dr Elliot Shevel is a South African migraine surgery pioneer and the founder and medical director of The Headache Clinic in Johannesburg, Durban and Cape Town, South Africa. The Headache Clinic is a multidisciplinary practice dedicated to the diagnosis and treatment of Primary Headaches and Migraines. Dr Shevel is also the main author of all scientific publications generated by his team. He recently won a high level science debate in which he was able to prove that the current migraine diagnosis and classification is not based on data. Tertiary Education - Dr Shevel holds both Dental and Medical degrees, and practises as a specialist Maxillo-facial and Oral Surgeon. Follow the Headache Clinic on Twitter@HeadacheClinic.

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