FDA approves new version of PerioChip

Dexcel Pharma's PerioChip is an adjunctive therapy for periodontal disease.

Dexcel Pharma yesterday announced that the US Food & Drug Administration approved PerioChip (chlorhexidine gluconate - 2.5mg) for shipment and storage at room temperature. This makes administering adjunctive therapy for periodontal disease with the PerioChip easier by enabling dental professionals to store the PerioChip close at hand.

PerioChip is a small biodegradable chip containing chlorhexidine gluconate that is easily inserted into the periodontal pocket around the tooth. It dissolves naturally in the pocket over seven to 10 days, killing all bacteria and inhibiting the proliferation of perio-pathogenic bacteria. PerioChip's active ingredient, chlorhexidine, is a gold-standard broad-spectrum antimicrobial agent. Patients can eat, drink, and brush their teeth as usual after treatment.

"To secure this new approval, we made slight modifications to the manufacturing process without altering the pharmacokinetics," said Dr. Adel Penhasi, VP R&D at Dexcel Pharma Technologies, the manufacturer of the PerioChip. "Now, even more than before, PerioChip meets the needs of the dental profession for a simple, effective, non-antibiotic adjunctive therapy in a convenient format that does not require special storage or tools for insertion."

Dexcel Pharma Technologies, established in 1965, and located in Israel, researches, develops, manufactures, and markets innovative and generic brand-name prescription and over-the-counter drugs and technologies. Its therapeutic specialties include oral health, women's health, cardiology, endocrinology, dermatology, neurology, anti-infectives, anti-cancer, musculo-skeletal, and contrast media (imaging). The company's technologies include a time-controlled delivery system, an oral controlled release patch, channeling tablet technology, and nanosphere preconcentrate technology.

Published by Globes [online] - www.globes.co.il - on 28 August 2002

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