Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Dental and Oral Health
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Periostat (doxycycline hyclate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: CollaGenex Pharmaceuticals
Approval Status: Approved February 2001
Treatment Area: Periodontal disease
Periostat is a twice daily, orally administered tablet that has
been approved as an adjunctive treatment to scaling and root
planing (SRP), a deep cleaning of the teeth and gums. This drug
promotes attachment level gain and reduces pocket depth in patients
with adult periodontitis. The capsule formulation of Periostat was
approved for use in September 1998.
Periodontitis is the most serious of the periodontal diseases,
commonly referred to as gum diseases. It is remarkably common in
adults over the age of 35, with some sources estimating that up to
one third of American adults suffer from some form of
periodontitis. The etiology of periodontitis is multifactorial. Its
nature and severity are determined by complex interactions between
infectious bacteria and a susceptible host. The end results of this
interaction are the bone and soft tissue destruction and attachment
loss that characterize periodontitis.
Current first-line therapies for periodontitis, such as SRP,
primarily address the bacterial component of the disease. If
indicated, SRP may be supplemented by antimicrobial drugs.
Periostat is the first and only drug designed to reduce the
activity of the enzymes that destroy tooth and gum tissue. When
prescribed as an adjunct to SRP, it has been shown to help slow the
progression of adult periodontitis more effectively than SRP
The efficacy of Periostat (doxycycline hyclate) as an adjunctive
treatment for adult periodontitis was established in a randomized,
multi-center, double-blind, nine month phase III study involving
190 subjects with periodontal disease. The effects of oral
administration of twice daily Periostat tablets in combination with
SRP procedures were compared to placebo plus SRP.
Results were based on measurements of pocket depth, attachment
level, and bleeding-on-probing. Such measurements were obtained
from the treated areas directly after SRP, after three months, six
months, and nine months. Periostat administered with SRP improved
clinical attachment level by up to 52 percent and reduced pocket
depth by as much as 67 percent compared to SRP plus placebo. These
benefits were observed as early as three months into the study and
were maintained over the nine month period of the trial.
Adverse events associated with the use of doxycycline hyclate
may include (but are not limited to) the following:
- Joint pain
Mechanism of Action
Periostat (doxycycline hyclate) is an oral enzyme inhibitor that
works by reducing the activity of host-derived enzymes, such as
collagenase. Collagenase has been shown to be associated with the
destruction of the periodontal support structures during the
progression of adult periodontitis. Periostat is administered
systemically, offering the additional advantage of being able to
treat all the tooth sites simultaneously, a whole-mouth approach to
the management of the host response.