August 11, 2009
Study Shows Novel, Orally Inhaled Migraine Therapy Effective
A new study conducted at the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania shows an investigational, orally-inhaled therapy is effective in treating migraines. The multi-center, phase three FREEDOM-301 trial for the orally-inhaled migraine therapy, LEVADEXÃ¢“¢, shows study participants had significant relief from symptoms such as pain, nausea and light and sound sensitivity when compared to placebo treatment. According to trial results, this therapy provided pain relief in 30 minutes and sustained relief for 48 hours after dosing in patients with moderate or severe migraine attacks. The drug was generally very well tolerated and there were no drug-related, serious adverse events reported.
According to the American Headache Society (AHS), migraine is a common, debilitating neurological disorder that affects approximately 30 million people in the United States. The AHS also states that most migraines last between four and 24 hours, but some may last as long as three days. Common associated symptoms of migraine include nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).
"The major advantage of LEVADEX is that it has the efficacy of intravenous DHE (dihydroergotamine) with a side-effect profile similar to placebo and better than oral triptans," said Stephen Silberstein, M.D., F.A.C.P, a clinical study investigator, director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University.
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