Source: DGNews  |  Posted 2 years ago

By Liz Meszaros

PHILADELPHIA -- September 15, 2009 -- MAP0004, a novel orally inhaled formulation of dihydroergotamine (DHE) currently under development, may be effective in treating a broad spectrum of migraine, according to 2 phase 3 studies presented here September 12 at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS).

In the first of these studies, researchers completed a post hoc analysis of a randomised, double-blind, placebo-controlled, 2-arm, multicentre study. In all, 903 patients were randomised, 811 patients experienced a qualifying migraine, and 792 patients who treated a qualifying migraine were included in the primary analysis.

In all, 61% of patients treated with MAP0004 had pain relief at 60 minutes, compared with 37% of those treated with placebo (P < .0001). At 2 hours, 70% of moderate patients treated with MAP0004 had pain relief, compared with 42% of placebo-treated patients (P < .0001). Pain relief response for MAP0004 in the severe patients was statistically significant compared with placebo at all time points starting at 10 minutes.

MAP0004 was also effective compared with placebo in patients with or without vomiting, with or without nausea, with or without aura, and in those currently using triptans at the time of entry into the study and those not using triptans.

In the second analysis, MAP0004 was equally effective in migraine with or without allodynia for 2-hour pain relief (57%, and 60%, respectively) compared with placebo (34% and 35%, respectively; P < .0001 for both), 2- to 24-hour pain relief, 2-hour pain-free state, and sustained 2- to 24-hour pain-free state.

“We have always known that DHE is effective in the treatment of migraine. But until now, the delivery methods we’ve had available until now, including parenteral and oral, have always been inconvenient for patients,” said investigator Stephen Silberstein, MD, Jefferson Headache Center, Department of Neurology, Jefferson Medical College, Philadelphia, Pennsylvania.

“This inhaled version is much more convenient for patients. In addition, we are able to deliver a much lower dosage, which is still efficacious but reduces side effects,” he added.

Data also showed that MAP0004 was effective regardless of how long patients waited to treat their migraines, whether that was within 1 hour, 1 to 4 hours, 4 to 8 hours, or after 8 hours of the start of headache. This is significant because studies have shown that delaying the treatment of migraine with agents such as sumatriptan by even 4 hours can reduce the response rate from 79% to 21%, noted Dr. Silberstein.

“In all paradigms of migraine -- with or without allodynia, morning-onset migraine, rest-of-the-day migraine, migraine with or without vomiting, with or without aura, and in migraineurs currently using or not using triptans -- [MAP0004] is effective, often within 10 minutes of treatment,” said Dr. Silberstein.

Funding for this study was provided by MAP Pharmaceuticals, Inc.

Presentation titles: Efficacy Evaluation of Levadex (Previously MAP0004) in Treating Resistant Migraine Including Migraine With Allodynia, Migraine Treated Late in Its Cycle, Morning Migraine and Disabling Migraine. Abstract LBP011.
and
Efficacy Evaluation of Levadex (Previously MAP0004) in Treating a Broad Spectrum of Acute Migraine Attacks Including Patients Using Triptans and Patients Not Using Triptans. Abstract LBP012