PerioChip(R) approved by FDA for room temperature storage
Dexcel Pharma Inc. has announced that the Food & Drug Administration (FDA) has approved PerioChip(R) (chlorhexidine gluconate - 2.5mg) for shipment and storage at room temperature. This makes administering adjunctive therapy for periodontal disease with the PerioChip(R) easier than ever before, by enabling dental professionals to store the PerioChip(R) close to hand in the operatory and access it as needed.
PerioChip(R) has proven efficacy and safety in the fight against periodontitis, a progressed form of gum disease. PerioChip(R) significantly reduces pocket depths as adjunctive therapy to scaling and root planing (SRP) compared to SRP alone*. PerioChip(R) is not an antibiotic and therefore is not associated with bacterial resistance. PerioChip(R) is a safe treatment of choice for periodontitis and can be used in periodontal maintenance programs with adverse events comparable to placebo.
PerioChip(R) 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(R)'s active ingredient, chlorhexidine, is a gold-standard broad-spectrum antimicrobial agent. Patients can eat, drink, and brush their teeth as usual after treatment.
New PerioChip(R), stored at room temperature, exemplifies Dexcel's commitment to the dental market and the fight against gum disease.
"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 Ltd., the manufacturer of the PerioChip(R). "Now, even more than before, PerioChip(R) 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."
PerioChip(R) is manufactured by Dexcel Pharma Technologies Ltd. It is available to dental professionals at tel. 1-866-PerioChip. Dexcel Pharma's Web site (www.periochip.com) contains professional and patient information. The site provides dental professionals with information on prescribing PerioChip(R) and on its mode of action, indication and usage, clinical efficacy, safety, and administration, as well as background information on Dexcel Pharma. Additional reading includes abstracts, references and case reports.
