Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Dental/Maxillofacial Surgery
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: OraPharma
Approval Status: Approved February 2001
Treatment Area: Periodontal disease
Arestin (minocycline hydrochloride) is indicated for the
adjunctive treatment of adult periodontitis following scaling and
root planing, which consist of deep cleaning of the teeth and gums.
It is painless to apply and is completely resorbed, leaving nothing
to be removed. Arestin is highly bioadhesive, not requiring any
retention dressings, and will not leak or fall out. The drug has
been studied only in patients with chronic periodontitis.
Periodontal disease is a vastly under treated health problem
that carries serious risks. It affects more than 50 million people
in the United States, though less than one-fifth of these
individuals receive treatment. Studies suggest a possible systemic
link between periodontal disease and overall health, including
conditions such as coronary heart disease, stroke, and
diabetes.
Clinical trials testing the safety and effectiveness of the
product were conducted in over 900 subjects with chronic
periodontitis. These landmark trials, conducted in 23 centers
across the United States, involved tens of thousands of individual
periodontal pockets. Treatment using Arestin following scaling and
root planing significantly reduced pocket depth compared with
scaling and root planing alone, even for the hardest to treat sites
and with the most challenging patients.
Adverse events associated with the general use of minocycline
may include (but are not limited to) the following:
- Nausea or diarrhea
- Dizziness
- Sensitivity to sun
- "Furry" or swollen tongue
Arestin uses patented microsphere technology to deliver
minocycline, a tetracycline antibiotic, beneath the gum, directly
into the infected periodontal pocket.
For additional information on Arestin, please visit
OraPharma.