Data evaluating the efficacy of triclosan as an antigingivitis ingredient do not support its inclusion as a Category I active in the OTC Antigingivitis/ Antiplaque Monograph, according to the oral care industry's two leading marketers, Procter & Gamble and Colgate-Palmolive.

The Crest and Colgate manufacturers voiced their opinions in response to FDA's call for safety and efficacy data in July as part of the agency's evaluation of .3% triclosan for inclusion in the monograph (¹ 'The Rose Sheet' July 5, 2004, In Brief).

FDA issued the data request after triclosan producer Ciba submitted a time and extent application last year urging the agency to consider including the ingredient based on the sale of oral care products containing triclosan in 13 countries for more than six years (² Also see "Triclosan Antigingivitis/Antiplaque Monograph Status Sought By Ciba" - HBW Insight, 8 December, 2003., p. 5). Ciba also noted that Colgate has marketed triclosan-containing Colgate Total in the U.S. under an NDA since 1997.

While adequate safety data supports the use of .3% triclosan in dentifrices and oral rinses and the ingredient has been shown to provide statistically significant reductions in plaque and malodor, data has not met the criteria established by FDA's Dental Plaque Subcommittee supporting triclosan as an antigingivitis agent, P&G asserts in its comments, submitted to the agency Sept. 30.

Citing six of its own "well-controlled, double-blind, parallel, randomized gingivitis effectiveness clinical trials on multiple triclosan-containing dentifrice formulations evaluating over 700 subjects," P&G concludes the ingredient has been shown to be "modestly effective" as an antigingivitis agent. The company's results have shown wide variations in effectiveness, however, from little to none to significant, the company points out.

Acknowledging Colgate's NDA, P&G says a product marketed under an NDA's "unique formulation does not necessarily provide general recognition of ingredient effectiveness."

"The OTC monograph process is an ingredient-based system that should not be constrained to a unique formulation, whereas the NDA process is limited to a specific formula with specific manufacturing controls," P&G explains.

The company admits it markets triclosan-containing dentifrices in Asia, Canada, Europe and Latin America. However, those products claim cosmetic benefits only and make no disease intervention or antigingivitis drug claims, the firm adds.

Before .3% triclosan is included in the monograph, it should meet the Plaque Subcommittee's "weight of evidence" requirements for efficacy in more than one formula. In addition, manufacturing controls, formulation and usage should be identified to explain the lack of gingivitis effectiveness in clinical trials, and a performance test should be established to ensure the efficacy of final formulation, P&G concludes.

In addition, no interim marketing of triclosan-containing products should be permitted in the absence of an approved NDA while FDA makes its final decision on the issue, P&G recommends.

Colgate agreed with P&G in an Oct. 4 filing, stating Ciba's TEA should be denied because there is insufficient data supporting the efficacy of triclosan outside of Colgate's own NDA formula.

The company cited clinical studies on the use of triclosan in multiple ingredient combinations - with pyrophosphate, calcium carbonate and potassium salts - all of which showed minimal or no antigingivitis efficacy, according to the firm.

"There is only one oral care product with triclosan as the sole antiplaque and antigingivitis active ingredient that meets FDA standards for efficacy: Colgate Total," the company states, reiterating the product is marketed with a patented formula under a proprietary NDA that FDA cannot rely upon in a TEA proceeding.

"It is clear that the NDA drug product has been successfully formulated to accomplish the important balance between solubility and bioavailability of triclosan," Colgate says. "Studies with other triclosan formulations have not demonstrated consistent or robust efficacy data."

In addition, Ciba does not cite any products in the TEA other than the NDA formula or those containing combination active ingredients that have been marketed with both antiplaque and antigingivitis claims, Colgate adds. If Ciba aims to take advantage of Colgate's research, the company should move forward with an abbreviated new drug application rather than a TEA, the company asserts. Colgate also intends to provide FDA with a follow up submission. In separate comments, Ciba defended its TEA (see ³ Also see "Crest Clinical Study Supports Triclosan Antigingivitis Efficacy – Ciba" - HBW Insight, 8 November, 2004. ).

Triclosan Antigingivitis Effectiveness Data Questioned By P&G, Colgate

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