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| |  Migranal Nasal Spray Available In U.S. For Migraine Headaches EAST HANOVER, NJ -- February 4, 1998 -- Migranal(R) (dihydroergotamine mesylate, USP) Nasal Spray, for the acute treatment of migraine headaches with or without aura, is now available by prescription at pharmacies across the United States. In clinical trials, self-administration of Migranal Nasal Spray resulted in migraine pain relief and a reduction in pain intensity. Over 50 percent of patients in pivotal clinical trials did not need additional medications during the 24-hour period following a single 2 mg Migranal treatment. Developed by Novartis Pharmaceuticals Corp., Migranal was cleared for marketing by the U.S. Food and Drug Administration on Dec. 8, 1997. The demand for Migranal is being fuelled in part by the frustration of migraine sufferers when their migraine comes back. "Many patients must take repeated doses of medication to gain relief for their migraine headache pain," said Stephen Silberstein, M.D., F.A.C.P., director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. "Not knowing whether or not their migraine pain may return can be anxiety-producing for patients and may lead to a feeling of loss of control over one's life. "A medication such as Migranal Nasal Spray may be ideal for migraine patients who require multiple doses to gain relief and is a welcome and much-needed addition to our current list of migraine treatment options." In clinical trials, Migranal Nasal Spray was shown to produce a reduction in nausea and sensitivity to both light and sound at two and four hours compared with placebo. Over 50% of patients in all pivotal clinical trials did not need additional migraine medications during the 24-hour period following a single 2 mg Migranal treatment. In addition, the nasal spray formulation bypasses the gastrointestinal tract, making it appropriate for patients who suffer from nausea and vomiting as a result of migraine and who may therefore have difficulty with oral treatments. Migranal Nasal Spray is a migraine-specific serotonin agonist. It attacks migraine at its source by selectively binding to receptors in the brain that regulate the release of serotonin, a chemical thought to play a major role in the development of migraine. Migranal is also non-narcotic, non-habit forming and non-sedating. In clinical trials, side effects were usually mild and transient. The most common were rhinitis, altered sense of taste, nausea, vomiting, dizziness and application site reaction. A package of Migranal Nasal Spray contains four complete migraine headache treatments. One treatment consists of a single spray (0.5 mg) administered into each nostril, followed by an additional spray administered into each nostril 15 minutes later, for a total of four sprays (2.0 mg). Migranal Nasal Spray is generally well-tolerated and its unique nasal spray formulation reduces concerns over gastrointestinal effects associated with oral treatments. Approximately 16-18 million Americans suffer from migraine. A migraine attack can last from four to 72 hours and consists of throbbing head pain which is often accompanied by nausea, vomiting and sensitivity to both light and sound. Many migraine sufferers experience pain so debilitating that they must abstain from their regular activities and rest in a dark quiet room. More information on: Novartis
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