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Home | Clinical Trials

FDA Approved Drugs » 1997
Medical Areas: Neurology | Family Medicine

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The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved December 1997
Treatment Area: migraine

General Information

Migranal (dihydroergotamine mesylate, USP) has been approved for the acute treatment of migraine headaches with or without aura.

Clinical Results

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.

Side Effects

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.

Mechanism of Action

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.

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