FOR IMMEDIATE RELEASE
Contact:
Todd Forte
Novartis Pharmaceuticals Corporation
(973) 503-5389
Julio Cantre
Porter Novelli
(212) 601-8280
NOVARTIS PHARMACEUTICALS CORPORATION RECEIVES FDA CLEARANCE TO MARKET MIGRANALÆ (dihydroergotamine mesylate, USP) NASAL SPRAY
-- New Migraine Formulation Offers Effective and Sustained Relief --
EAST HANOVER, NJ (December 10, 1997) -- Novartis Pharmaceuticals Corporation announced today that it received clearance from the U.S. Food and Drug Administration to market MigranalÆ (dihydroergotamine mesylate, USP) Nasal Spray for the acute treatment of migraine headache with or without aura.
"Until now, many patients had to take repeat doses of their migraine medication in order to receive complete relief," said Stephen D. Silberstein, M.D., F.A.C.P., director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. "Migranal Nasal Spray has the advantage of providing rapid and sustained migraine relief in one treatment."
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.
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 noise. For many sufferers, the pain from a migraine attack can be so severe that they are forced to discontinue their regular activities and to rest in a quiet, darkened room.
Other types of medications currently indicated to treat migraine include subcutaneous injection (just beneath the skin), intramuscular or intravenous injection administered by a medical professional, intranasal administration and pill formulations. The addition of a safe, effective nasal spray for the treatment of migraine provides an important therapeutic option for patients who dislike injections or who cannot tolerate pills due to nausea and vomiting.
"Migraine attacks can be debilitating," said Dan Ventura, Ph.D., a director of the Nervous System Unit in the Division of Research and Development at Novartis Pharmaceuticals Corporation. "It is encouraging news for migraine sufferers and their families that there is now a medication available in intranasal form for those who suffer from migraine and who may have difficulty with existing forms of therapy."
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. Migranal Nasal Spray is non-narcotic, non-habit forming and nonsedating. 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 will be available to patients by prescription in January 1998.
Novartis Pharmaceuticals Corporation (U.S.) researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, cancer and arthritis. The companyÃs mission is to improve peopleÃs lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals is an affiliate of the Novartis Group, a world leader in Life Sciences, with core businesses in Healthcare, Agribusiness and Nutrition. In 1996, Novartis achieved Group sales of 27.6 billion Swiss francs (U.S. $22.3 billion) and invested in more than 3 billion Swiss francs (U.S. $2.4 billion) in research and development. Headquartered in Basel, Switzerland, Novartis employs approximately 88,000 people in more than 100 countries. # # #
Please call Todd Forte at Novartis Pharmaceuticals Corporation (973-503-5389) for full prescribing information.
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