Periostat Filed In First European Market

23 July 1997

Boehringer Mannheim Italia has filed for approval of Periostat(doxycycline) in Italy, the first in a series of planned European submissions for the low-dose formulation of the drug, which is intended for the treatment of periodontal disease. BMI licenses the product from CollaGenex of the USA, where it is also pending approval.

Periostat is the first orally-administered systemic drug developed for this indication. Its activity in this disease derives not from antimicrobial action, but rather from its ability to inhibit collagenase and matrix metalloproteinases thought to be involved in the tissue destruction.

Clinical trials in more than 400 patients, reported at the International Association for Dental Research meeting in March, showed that Periostat at a dose of 20mg twice-daily can reduce bone loss, gum detachment and bleeding in patients with periodontal disease. The data suggest that the drug can put the disease into a holding pattern, buying time until dental therapy can be carried out.

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