Tioconazole

It will be hard for the Food Drug Administration to match the torrid pace it set during the previous 12 months when it approved nine Rx-to-OTC switches. However, a fair number of prescription drug conversions are still expected to gain OTC marketing clearance and arrive on store shelves by this time next year.

Cholesterol-lowering products, transdermal smoking cessation aids, acne and herpes treatments and single-dose vaginal anti-fungals are among those mentioned as the most likely candidates, according to sources familiar with FDA proceedings and the nonprescription drug industry.

One good indication that Rx-to-OTC switch activity will remain high is the full slate of meetings scheduled for the FDA's Nonprescription Drugs, Advisory Committee (NDAC). This group has been involved in nearly every switch since it first met in 1992. And although agenda topics aren't disclosed, the group is scheduled to hold a series of two-day meetings in June, August, October and December.

Simply keeping tabs on the advisory committee doesn't present the full switch picture, however, as the FDA doesn't require all products to appear before the committee. The recent switch of Femstat 3 is a good example. Other indicators of switch products to come are overseas markets such as the United Kingdom and neighboring Canada.

The following are among the categories and products to watch closely during the coming year:

SMOKING CESSATION: Nicorette from SmithKline Beecham is already available OTC, and it looks like Nicotrol from Johnson & Johnson and Nicoderm also from SmithKline Beecham will soon be on store shelves. At an NDAC meeting on April 19, the committee voted in favor of allowing the products to be sold without a prescription.

Nicotrol is a Pharmacia & Upjohn product that Warner-Lambert originally planned to market OTC. However, J&J acquired the OTC marketing rights last year. Nicoderm is an Alza Corp. product that will be marketed by SmithKline Beecham.

Expected to eventually join those products are the Prostep nicotine patch from Elan Corp. and the Habitrol nicotine patch from Ciba-Geigy Corp. Rx-to-OTC switch applications for both products have been submitted to the FDA.

The eventual availability of five smoking cessation products is sure to set off an ad blitz. Consumer confusion is practically assured considering three of the five brand names begin with the prefix "nico."

VAGINAIL ANTI-FUNGALS: An OTC category created in early 1991 with the switch of miconazole and clotrimazole, this category is evolving quickly toward the availability of shorter durations of therapy. In today's market, seven-day treatment regimens dominate. However, the April launch of Femstat 3 (butoconazole nitrate 2%) from the Procter Syntex Health Products Co. gave consumers access to the first OTC three-day treatment. A Monistat 3 product from J&J's Advanced Care Products division is also expected to arrive in stores soon.

The first one-day OTC therapy appears to be just around the corner. Bristol-Myers Squibb is seeking OTC marketing clearance for Vagistat-1 (tioconazole 6.5%). The topically applied ointment received OTC approval in the United Kingdom in January 1994.

The single-dose oral anti-fungal Diflucan (fluconazole) from Pfizer is also mentioned as a potential switch candidate. However, a high prevalence of side effects (headache and nausea) is said to limit the likelihood that Diflucan will secure OTC marketing clearance soon.

Vagistat-1 and Monistat 3 are currently available without a prescription Canada.

CHOLESTEROL-LOWERING AGENTS: Questran and Questran Light from Bristol-Myers Squibb, known generically as cholestyramine, had 1995 sales of $97 million. Their Rx-to-OTC switch application was discussed b the NDAC on Sept. 27. However, at that time the panel found the data presented didn't warrant the OTC availability of Questran and Questran Light.

That decision wasn't a complete rejection of the products. It merely sent Bristol-Myers Squibb back to the drawing board. "We are in the process of working with FDA on a consumer usage study that is progressing very well and we are fully committed to the switch of the product," said a company spokesman. The manufacturer's most recent annual report indicates that it hopes to begin marketing an OTC version of Questran during 1997.

Meanwhile, the prescription version of Questran is encountering its first generic competition. Upsher-Smith was granted ANDA approval on Feb. 22 for a generic prescription version of cholestyramine.

ACNE: The acne treatment category could get a shot in the arm with the switch of topical erythromycin. The prescription drug was reviewed by the NDAC at a meeting on Nov. 16, 1994. However, the panel recommended against the drug's OTC availability, expressing concems about users developing increased bacterial resistance to the drug and the need for more data. Those familiar with NDAC said it wouldn't surprise them to see the drug come up for review again this year. If switched, topical erythromycin would compete against such familiar anti-acne active ingredients as benzoyl peroxide and salicylic acid.

HERPES: The Burroughs Wellcome drug Zovirax (acyclovir) for the treatment of recurrent genital herpes was reviewed by two FDA advisory committees on May 19, 1994. Concerns about off-label uses for treatment of cold sores and the possibility that misuse of the drug could lead to increased viral resistance put the switch on hold. The safety and efficacy of the drug were not sticking points on approving the switch.

The product is reportedly still under consideration at the FDA as the manufacturer completes additional studies.

HEARTBURN: The latest drug to join the plethora of heartburn treatments now available could be Carafate (sulcrafate 1 mg) from Hoechst Marion Roussel. Those familiar with FDA advisory committees believe the drug could be considered as a switch candidate. Serving as an added incentive for the manufacturer is the fact that Carafate recently lost its patent and on March 29 Biocraft Labs received ANDA approval for sucralfate lmg. Carafate had 1994 sales of $147 million, according to its manufacturer. The prescription drug is indicated for the short-teriin and maintenance therapy of active duodenal ulcers.

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