Ortek CaviStat Anticaries Ingredient Approval To Be Sought By Late 2003
This article was originally published in The Rose Sheet
Executive Summary
Ortek Therapeutics expects to apply for FDA approval of its arginine/bicarbonate/calcium carbonate anticaries ingredient CaviStat by the end of the year
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Ortek Therapeutics expects to apply for FDA approval of its arginine/bicarbonate/calcium carbonate anticaries ingredient CaviStat by the end of the year. Ortek is "currently evaluating regulatory strategies to commercialize CaviStat as quickly as possible" for consumer products, the company said June 24. While Ortek has not yet determined which regulatory approach to take for CaviStat, an Rx version of the dentifrice was approved under a 510(k) device application in February 2001. The firm plans to begin marketing the Rx "topical desensitizing dental crème" as Denclude in Q4. Ortek also announced that a two-year pediatric trial indicated brushing with CaviStat three times per day leads to 96.6% fewer cavities than brushing with a fluoride dentifrice. The company-sponsored study was scheduled to be presented at the International Association of Dental Research's 81st General Session in Goteborg, Sweden June 28. The study enrolled 726 Venezuelan children ages 11 and 12 with decayed/missing/filled teeth (DMFT) scores of between three and six, according to Ortek. Of the participants, 321 using CaviStat and 331 using fluoride completed the study. The subjects were evaluated at baseline, six months, and one and two years through probing and decayed/missing/filled surface (DMFS) scoring. While DMFS rose in the fluoride group after one year, group DMFS in the CaviStat arm decreased, Ortek said. After two years, DMFS scores rose .87 in the fluoride group and .03 in the CaviStat group. The trial was conducted at the University of Central Venezuela, Caracas, and the State University of New York at Stony Brook; SUNY's research foundation has licensed the worldwide rights to CaviStat to Ortek. Marketing for a consumer version could highlight the product's lack of fluoride, which can cause dental fluorosis, a discoloring of the teeth. Ortek said the ingredients in CaviStat "are food grade...and, unlike fluoride, are safe for children to swallow in a toothpaste and can be added to candies and gum." In fact, Ortek said it has created prototypes of confectionery delivery forms for the product, but has not yet clinically tested them. |