Drug Profiles:
Migranal® (dihydroergotamine mesylate, USP)

CAUTION: Federal law prohibits dispensing without prescription.

Migranal® Nasal Spray is now available to treat migraines-

Migranal is the only anti-Migraine aportive non-triptan treatment. Migranal Nasal Spray is a non-triptan therapy with a distinctly different chemical compound. In addition, it has an extremely long halflife of 10 hours.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray, for the acute treatment of migraine with or without aura, is now available by prescription at pharmacies nationwide. In clinical trials, self-administration of Migranal® Nasal Spray resulted in migraine pain relief and a reduction in pain intensity. Over 50% 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 Corporation, Migranal® was cleared for marketing by the U.S. Food and Drug Administration on December 8, 1997.

"Migranal® Nasal Spray represents an important new treatment option for migraine sufferers. We are pleased to be able to offer this nasal spray formulation, which is easy and convenient to use," said Wayne Yetter, President and CEO of Novartis, maker of Migranal®.

The demand for Migranal® is being fueled 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 pain," said Stephen D. 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," he said.

In a recent survey* of 1,000 diagnosed migraine sufferers who have taken prescription medication for migraine headache, 62% reported a return of migraine after taking prescription treatment at least occasionally; 19% reported that this occurs regularly. More than 70% of respondents reported that their lives come to a standstill at the return of migraine and that their inability to get total relief from migraine makes them feel helpless. Migranal® Nasal Spray may be ideal for migraine patients who require multiple doses to gain relief from migraine.

In clinical trials, Migranal® Nasal Spray was shown to produce a reduction in nausea and sensitivity to both light and sound at 2 and 4 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 nonnarcotic, non-habit forming, and nonsedating.

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 treatments. One treatment consists of a single spray (0.5 mg) administered into each nostril, followed by an additional spray administered into each nostril fifteen 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.

*A sample of 1,000 migraine sufferers who are currently taking prescription medication or have taken prescription migraine medication in the past was interviewed by telephone December 8-21, 1997. The survey was conducted by NFO Research Inc. of Toledo, OH for Novartis Pharmaceuticals Corporation.