Administration of ARESTIN®

June 24, 2005
Steps to take in the treatment of periodontal disease by local administration of ARESTIN (minocycline microspheres).

Treating chronic adult periodontitis presents many challenges. Research has shown that chronic periodontitis is not a slowly progressing inflammatory disease, but rather an infection that is characterized by spontaneous bursts of disease activity in random sites. These sites may exhibit activity from a few days to a few months before becoming dormant, only to reappear once again over time. But if left untreated, periodontitis can result in loss of the tissues that surround and support the teeth, including the gums, cementum, periodontal ligament, and alveolar bone.

While mechanical therapy is still considered the gold standard for treatment of adult periodontitis, it does not completely eliminate the bacteria from the body or surrounding tissues, and reinfection of periodontal pockets from recolonization of the bacteria responsible for periodontal disease can occur within 60 days of scaling and/or root planing (SRP) alone. Because periodontal diseases are caused by specific bacteria, certain antimicrobial agents can reduce or eliminate the infection.

ARESTIN (minocycline HCl) 1mg Microspheres, when used after SRP, has been proven to reduce pocket depth significantly more than SRP alone. In fact, in a clinical study involving 748 patients with probing depths of 6-9mm, more than 60 percent of responding pockets had a reduction of ≥2mm.

Benefits of ARESTIN for patients and dental practices:

No compliance nightmares: One of the biggest benefits of locally delivered therapeutics is that there are no compliance issues as with oral medications, since patients do not have to remember to take the drug.

Regain the proper balance: Additionally, ARESTIN minocycline microspheres release therapeutic doses of the drug directly at the site of infection, eradicating bacteria for more than 21 days longer than any of the other currently available locally administered antibiotics (LAAs). With the bacterial load being lowered, the body is then able to regain equilibrium within the pockets and reduce the clinical signs of the disease. Upon recare, clinicians will see improvement in these signs and, if refractory sites remain, can retreat during the same appointment.

Site-specific with no bacterial resistance issues: ARESTIN can be placed adjacent to the periodontium, leaving other parts of the body unaffected. Studies show that treatment with ARESTIN does not disrupt the normal intestinal flora, and results in no overgrowth of foreign pathogens or increase in antibiotic resistance.

Fast, easy and painless: ARESTIN provides fast, easy and effective treatment of adult periodontitis without the need for local anesthesia. The bioresorbable minocycline microspheres adhere to pocket surfaces on contact with crevicular fluid, and require no dressings or dental adhesives. Up to 30 sites can be treated in less than 10 minutes using the simple unit-dose delivery method described below:

How to use ARESTIN:

Step 1: Insert the ARESTIN cartridge into the handle while exerting slight pressure.

Step 2: Twist until you feel and hear the cartridge "lock" into place.

Step 3: Should you need to manipulate the cartridge tip to reach difficult-to-access areas, gently bend the tip, leaving the blue cap on. Bending the tip after removal of the blue cap may cause the internal plunger to rupture the cartridge wall.

Step 4: Place the cartridge tip into the periodontal pocket, parallel to the long axis of the tooth. Be sure not to force the tip into the base of the pocket.

Step 5: Gently press the thumb ring to express the ARESTIN powder while withdrawing the cartridge tip away from the base of the pocket. If you feel any resistance during delivery, withdraw the device further.

Step 6: Once delivery is complete, retract the thumb ring and remove the ARESTIN cartridge with your free hand. Appropriately discard the cartridge and sterilize the handle prior to reuse.

OraPharma, Inc. is a specialty pharmaceutical company that discovers, develops and commercializes therapeutics for oral health. A member of the Johnson & Johnson family of consumer companies, OraPharma is dedicated to the dental community, specifically the periodontal sector, with its lead product, ARESTIN. In June 2005, OraPharma was rated as the top company for customer support by a survey of dental health professionals recently conducted by Health Products Research, Inc. (HPR). 76% of respondents in the survey reported that OraPharma provides the best level of customer support to their practice among companies with an interest in the management of periodontal disease.

For more information about OraPharma, Inc., visit www.orapharma.com. For more specific information about ARESTIN®, visit www.arestin.com.