Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: Neurology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Novartis
Approval Status: Approved December 1997
Treatment Area: migraine
Migranal (dihydroergotamine mesylate, USP) has been approved for
the acute treatment of migraine headaches with or without aura.
In clinical trials, self-administration of Migranal Nasal Spray
resulted in significant pain relief and decreases in pain intensity
and nausea compared with placebo. In the two most recent clinical
trials, patients began to feel headache relief as early as 30
minutes after treatment with Migranal Nasal Spray. In those same
trials, up to 60% of patients responded by two hours, and up to 70%
responded by four hours, following a single 2 mg Migranal
treatment. The majority of patients in all pivotal clinical trials
did not need additional medications for their migraine headaches
during the 24 hour period following a single 2 mg Migranal
treatment.
In clinical trials, side effects were usually mild and
transient; the most common were rhinitis, altered sense of taste,
dizziness, nausea, vomiting, and application site reaction.
Migranal Nasal Spray is a migraine-specific serotonin agonist
that works at multiple receptor sites. Migranal Nasal Spray attacks
migraine at its source by selectively binding to receptors in the
brain that regulate the release of serotonin, a chemical considered
to play a key role in the development of migraine.