Arestin® (minocycline hydrochloride) Microspheres is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) or PGLA, for professional subgingival administration into periodontal pockets. Each unit-dose cartridge delivers minocycline hydrochloride equivalent to 1 mg of minocycline free base.

Minocycline, a member of the tetracycline class of antibiotics, has a broad spectrum of activity.1 It is bacteriostatic and exerts its antimicrobial activity by inhibiting protein synthesis.1 In vitro susceptibility testing has shown that the organisms Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum, Eikenella corrodens, and Actinobacillus actinomycetemcomitans, which are associated with periodontal disease, are susceptible to minocycline at concentrations of ≤8 μg/mL2; qualitative and quantitative changes in plaque microorganisms have not been demonstrated in patients with periodontitis, using this product. The emergence of minocycline-resistant bacteria in single-site plaque samples was studied in subjects before and after treatment with Arestin® at 2 centers. There was a slight increase in the numbers of minocycline-resistant bacteria at the end of the 9-month study period, however, the number of subjects studied was small and the clinical significance of these findings is unknown. The emergence of minocycline-resistant bacteria and changes in the presence of Candida albicans and Staphylococcus aureus in the gastrointestinal tract were studied in subjects treated with Arestin® in one phase 3 study. No changes in the presence of minocycline-resistant bacteria or C albicans or S aureus were seen at the end of the 56-day study period.

In a pharmacokinetic study, 18 patients (10 men and 8 women) with moderate to advanced chronic periodontitis were treated with a mean dose of 46.2 mg (25 to 112 unit doses) of Arestin®. After fasting for at least 10 hours, patients received subgingival application of Arestin®(1 mg per treatment site) following scaling and root planing at a minimum of 30 sites on at least 8 teeth. Investigational drug was administered to all eligible sites ≥5 mm in probing depth. Mean dose normalized saliva AUC and Cmax were found to be approximately 125 and 1000 times higher than those of serum parameters, respectively.

Clinical Studies
In 2 well-controlled, multicenter, investigator-blind, vehicle-controlled, parallel-design studies (3 arms), 748 patients (study OPI-103A = 368, study OPI-103B = 380) with generalized moderate to advanced adult periodontitis characterized by a mean probing depth of 5.90 and 5.81 mm, respectively, were enrolled. Subjects received 1 of 3 treatments: (1) scaling and root planing, (2) scaling and root planing + vehicle (bioresorbable polymer, PGLA), and (3) scaling and root planing + Arestin®. To qualify for the study, patients were required to have 4 teeth with periodontal pockets of 6 to 9 mm that bled on probing. However, treatment was administered to all sites with mean probing depths of 5 mm or greater. Patients studied were in good general health. Patients with poor glycemic control or active infectious diseases were excluded from the studies. Retreatment occurred at 3 and 6 months after initial treatment, and any new site with pocket depth ≥5 mm also received treatment.



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