ACTISITE CLEARED FOR MARKET IN USA

Alza Corp's Actisite (tetracycline HCl) Periodontal Fiber has been cleared for marketing by the US Food and Drug Administration. The product is the first and only sustained-release, site-specific product cleared for marketing in the USA for the treatment of adult patients with periodontitis.

The product, consisting of a copolymer fiber containing a low dose of the antibiotic tetracycline, is placed in the periodontal pocket by the dental practitioner. Active compound leeches out of the fiber in a controlled, continuous fashion over a ten-day treatment period. The product is indicated "as an adjunct to scaling and root planing for reduction of pocket depth and bleeding on probing in patients with periodontitis," a progressive multifaceted disease that attacks the supporting structures of the teeth. The most common adverse reactions to the product are limited to pain on fiber placement (10% of patients) and local inflammation following removal (11%), according to Alza.

Actisite will be marketed jointly in the USA by a partnership between Alza and Procter & Gamble. The companies say they anticipate launching the product, through dental centers, within the next several months. Procter & Gamble has a well-developed oral care product line, including non-prescription products such as Crest toothpaste, Scope mouth rinse and Crest Complete toothbrushes, as well as Peridex prescription rinse for the treatment of gingivitis.