The Prevention of Adult Caries Study of Prevora Achieves Full Enrolment.
CHX Technologies Inc., a specialty pharmaceutical company developing new preventive products for adult oral diseases, announced today that the Prevention of Adult Caries Study (PACS) of the antibacterial tooth coating called Prevora (100 mg/ml chlorhexidine acetate) has completed enrolment of study participants. Recruitment started in spring 2007, and 983 participants have been randomized in PACS.
PACS is a pivotal Phase III randomized, controlled clinical trial conducted under CHX Technologies’ Investigational New Drug license with the U.S. Food and Drug Administration. The study is expected to be the final study before filing a New Drug Application for Prevora to the FDA and is believed to be the largest study of its kind. PACS’ clinical endpoint is decayed tooth surfaces and the trial’s threshold for efficacy is a 20% reduction of such surfaces in the treated arm of the study versus placebo over one year. Efficacy results from PACS are expected in the first half of 2010.
Tooth decay has become a common adult disease as the population ages. The U.S. Center for Disease Control reported last year, for example, that about one third of American seniors under age 74 had tooth decay at the gum line (also called root caries). Root caries is caused by a low-grade asymptomatic bacterial infection. Its emergence in older Americans is largely related to gum recession and the taking of several prescription drugs each day. It is a form of tooth decay which is difficult to treat with conventional restorative procedures and which has been reported to have connections to overall health.
Prevora is a clear and temporary tooth coating applied by the dental professional to the teeth of adult patients in a short, painless appointment. Prevora is the first new antibacterial product indicated for the reduction of adult tooth decay available to the dental professional. It is also the first product in CHX Technologies’ development program which is uniquely focused on new proven preventive dental products for the aging population.
For more information contact:
Ross Perry, CHX Technologies Inc.