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Noven receives FDA clearance for dental anesthetic patch; DentiPatch is the first patch for drug delivery in the mouth.

MIAMI--(BUSINESS WIRE)--May 22, 1996--Noven Pharmaceuticals Inc. (NASDAQ:NOVN) Tuesday announced that it has received U.S. marketing clearance from the Food and Drug Administration for DentiPatch(tm) lidocaine transoral delivery system, a dental anesthetic patch for the prevention of pain from oral injections and soft-tissue dental procedures.

The DentiPatch system is a small adhesive strip that contains lidocaine, the most frequently used anesthetic in dentistry. Clinical trials have demonstrated that the transoral patch effectively numbs the area covered by the patch in about two minutes, and remains effective for up to 45 minutes. DentiPatch is also safe, with negligible systemic absorption of the anesthetic.

"DentiPatch is the first topical anesthetic clinically proven to prevent injection pain when large dental needles are inserted to the bone," said Elliot V. Hersh, DMD, Ph.D., director of Pharmacology and Clinical Therapeutics, University of Pennsylvania School of Dental Medicine, and a lead investigator of the clinical trials.

According to the American Dental Association, an estimated 10 million Americans are so afraid of needle pain that they simply refuse to have their teeth examined. By avoiding preventive dental care, these so-called "needle phobics" may encounter more serious dental problems in the long run. "DentiPatch can play an important role in breaking down the anxiety that prevents millions of people from getting proper dental care," said Mark Slovin, DDS, director of the Dental Phobia Clinic at the State University of New York at Stony Brook.

DentiPatch, which will be available later this year, is the first product to be marketed by Miami-based Noven. The company's estrogen replacement patch -- marketed in the United States as Vivelle(tm) by Ciba-Geigy, and abroad as Menorest by Rhone-Poulenc Rorer, made its worldwide debut recently. Noven received nearly $9 million in revenues from these products during 1995.

"DentiPatch will enable Noven to become a fully integrated pharmaceutical organization," said Steven Sablotsky, chairman and president, Noven Pharmaceuticals Inc. "We anticipate strong demand for DentiPatch, a truly novel dental anesthetic that can be used in a wide range of dental procedures."

DentiPatch -- the first transoral patch -- may augur a new generation of therapeutic products that are delivered intraorally. "The unique delivery system used in DentiPatch may not be limited to dental applications," said Robin J. Norris, MD, chief operating officer, Noven Pharmaceuticals Inc. "Transoral delivery would be ideal for many other types of medications such as peptides and proteins, that cannot be administered by conventional tablet form."

Noven Pharmaceuticals Inc. is an industry leader in the development and commercialization of advanced drug delivery technologies. The company's transdermal estrogen patch has been approved in 20 countries including the United States, France, Germany and the United Kingdom.

Noven is developing additional drug-delivery systems for a broad range of applications including hormone-replacement therapy, pain relief, asthma, neurological disorders, anxiety, cardiovascular disease and antifungal therapy.

CONTACT: Noven Pharmaceuticals Inc.

Mitchell Goldberg, Executive Vice President

516/739-0536 or 305/253-5099
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Publication:Business Wire
Date:May 22, 1996
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