ELAN/LEDERLE's PROSTEP NICOTINE PATCH SHIPPING NOW following Jan. 28 approval by FDA. Prostep will be the third transdermal nicotine smoking cessation patch to hit the market in the last six weeks behind Marion Merrell Dow/Alza's Nicoderm and Ciba-Geigy's Habitrol. Lederle, which will market the patch in the U.S. for Irish manufacturer Elan, said ProStep will be available to consumers by Valentine's Day. All three patches are indicated for use "as an aid to smoking cessation for the relief of nicotine withdrawal symptoms," approved labeling states. Lederle said ProStep will cost consumers about $4 a day, while Ciba-Geigy and Marion Merrell Dow have said their products will cost about $3 a day at retail. ProStep could make up for its apparently higher price by offering consumers a shorter duration of therapy -- four to eight weeks -- instead of the 10 indicated for Habitrol and Nicoderm. ProStep product labeling states that patients "who have successfully stopped smoking during that time [four to eight weeks] may have ProStep therapy discontinued." However, labeling adds, "if a gradual reduction is desired, patients may be treated for an additional two to four weeks, after which treatment should be terminated." ProStep also differs from Nicoderm and Habitrol in that most patients will use a single dosage strength (22 mg) throughout the treatment period. Habitrol and Nicoderm both use three declining dosage levels meant to gradually wean patients off of nicotine. ProStep also comes in an 11 mg patch, which can be used for "patients who weigh less than 100 pounds" or as an optional weaning dose to taper off nicotine consumption more gradually. Like Habitrol and Nicoderm, ProStep comes with a patient support program, including brochures on avoiding relapse. Habitrol and Nicoderm also provide self-help videotapes, while ProStep also offers a one-on-one counseling hotline that will advise patients and refer them to local smoking cessation support groups, Lederle said. ProStep received a "3s" rating for FDA, meaning a new formulation given standard, as opposed to priority, treatment by the agency. FDA began using the new rating system, which was recommended by Vice President Quayle's Council on Competitiveness, on Jan. 1 ("The Pink Sheet" Jan. 13, In Brief). All three approved nicotine patches deliver nicotine for 24 hours. The fourth contender in the burgeoning category is the Nicotrol 16 patch made by Cygnus Therapeutic Systems and licensed by Kabi to Warner-Lambert. Cygnus has said that its 16-hour patch will reduce the primary side effects of the 24-hour patches -- disturbed sleep and nightmares. Although Alza received approval for Nicoderm on Nov. 7, marketing partner Marion Merrell Dow was not allowed to ship the product due to a temporary restraining order placed on the company as part of Elan and Lederle's patent suit against the companies ("The Pink Sheet" Nov. 25, T&G-4). The order was lifted Dec. 13 and MMD began Nicoderm shipments the same day ("The Pink Sheet" Dec. 16, T&G-3). As a result of Nicoderm's delay, Ciba-Geigy's Habitrol came on the market at almost the same time, gaining approval on Nov. 27 and becoming nationally available before Christmas ("The Pink Sheet" Dec. 9, T&G-1). In one of the patent battles surrounding the nicotine patch products, a scheduled Jan. 28 hearing for Ciba-Geigy's motion for a preliminary injunction against the marketing of ProStep was canceled with no new date set. On Dec. 18, Elan/Lederle withdrew their motion for a similar preliminary injunction against the marketing of Habitrol ("The Pink Sheet" Jan. 6, T&G-7). Ciba-Geigy announced Feb. 1 that Habitrol would be one of the products to be marketed by its new Basel Pharmaceuticals Division sales force, which began detailing early in 1992. Other products to be promoted by the 353-person force are Anafranil (clomipramine) and Tegretol (carbamazepine). Lopressor (metoprolol) will be detailed in conjunction with the company's Geigy salesforce, Ciba-Geigy said.
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