If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Basis for Nicotine Inhaler Recommended by FDA Advisory Committee SAN ANTONIO, Dec. 13, 1996 -- Advanced Therapeutic Products, Inc. (ATP), announced that the Drug Abuse Advisory Committee of the U.S. Food and Drug Administration (FDA) voted today to recommend that the FDA clear the Nicotrol(R) Inhaler for marketing as a prescription nicotine replacement therapy (NRT). In 1987, ATP sold their patented nicotine technology which forms the basis of the Inhaler, to what is now Pharmacia & Upjohn, in exchange for future royalties equal to approximately 3 percent of net sales to wholesale distributors. Since then, together ATP and Pharmacia & Upjohn have further developed the Inhaler. If cleared by the FDA, the product will be marketed in the United States as the Nicotrol(R) Inhaler by McNeil Consumer Products, a Johnson & Johnson company. Information presented to the FDA committee stated that the innovative Inhaler will help smokers kick their habit by being the first NRT to control a smoker's cravings for cigarettes by addressing key behavioral components of smoking addiction. The Inhaler's delivery system sets it apart from currently available NRTs by addressing the hand-to-mouth motions that a smoker repeats 200 times a day, 73,000 times each year. In addition, the Inhaler gives smokers a sensation in the back of the throat similar to the feeling of inhaling smoke from a cigarette, without the harmful effects. The Inhaler consists of a mouthpiece and a cartridge containing a nicotine-impregnated plug. The smoker inhales through the mouthpiece, and the inhaled air becomes saturated with nicotine, which is absorbed almost completely through the lining of the mouth. Each puff of the Inhaler contains eight-to-ten times less nicotine than a puff of a cigarette. Outside the United States, the product is sold as the Nicorette(R) Inhaler and is available over-the-counter (OTC) is Denmark and will debut this month in Sweden. The Inhaler has also been approved for OTC sale in Italy and has applications pending for OTC sale in five other countries - including Great Britain. It has received Rx approval in the Netherlands and Rx applications are pending in five additional countries. ATP (NASDAQ "Advanced Tobacco Products, Inc.") is traded on the NASDAQ electronic "Bulletin Board" quotation system under the symbol AVTH.
|
