TORONTO, Aug. 25 /CNW/ - CHX Technologies Inc., a private Canadian
pharmaceutical company that is developing new treatments for the
prevention of dental diseases, today announced successful results in its
final controlled pivotal trial of Prevora, its proprietary antibacterial
tooth coating for the prevention of cavities. The trial surpassed
objectives set by the Food and Drug Administration (FDA) protocol,
clearing the way for CHX to start the process of seeking FDA approval
for use in the United States. In this study Prevora was shown to reduce
cavities by 37% (p = 0.04) over one year in all participants, and most
profoundly, by 60% (p=0.006) amongst participants at study sites with
the most severe levels of decay. For this study the FDA set an objective
of 20% reduction of cavities at p ≤ 0.05.
Prevora is a proprietary topical coating developed by CHX which is
applied to the teeth of the patient by the hygienist in a short,
painless appointment. The active ingredient, chlorhexidine, is a
well-known antiseptic used in both dentistry and medicine. Prevora
works by attacking the bacteria Streptococci mutans, which cause tooth
Tooth decay is the most common infection in adults, ranks as one of the
most expensive diseases and is implicated as a significant contributor
to overall health. The U.S. Center for Disease Control reports that 23%
of American adults have untreated tooth decay.
The Phase IIIB study of Prevora found that the worst tooth decay was
amongst the uninsured and public health groups, which account for half
of Americans today. The number of uninsured Americans is growing
quickly as baby boomers retire, as large employers change their benefit
plans, and as working in small business or being self-employed becomes
"In this context, Prevora's profound prevention of tooth decay,
especially for the uninsured, is timely and creates a new, painless and
effective preventive service for the dental office to offer a changing
market." said Ross Perry, President of CHX.
About the Pivotal Study: This study was a randomized,
placebo-controlled, double-blinded prospective study conducted according
to a protocol developed with the FDA. It involved 983 adults with mean
age of 43 years. The study participants had at least one cavity upon
screening, and were recruited so that they were representative of how
Americans pay for their dental care. Six out of 10 participants had
dental insurance, 4 in 10 were uninsured or received public health care.
There was a significant range of cavities in the study participants,
making the results generalisable to the American adult population. In
this study, Prevora or its placebo was topically applied by the dental
hygienist in five short appointments and observed over 13 months.
About the prevention of cavities in adults: Currently, there are no
treatments for adult tooth decay which are proven in randomized
controlled studies nor are there any approved preventive treatments to
be used in the dental office specifically for adult cavities in the
United States. Prevora fills this need.
About Prevora: Prevora has successfully completed three randomized
controlled studies in a spectrum of at-risk patients. Prevora is
approved in Canada and Ireland as an in-office prescription preventive
treatment for cavities at the gum line, the most common form of decay
after age 60. CHX has submitted the results of this Phase IIIB study to
European regulatory authorities for broader approvals of Prevora in the
European Union, and intends to meet with the FDA to define a critical
path for submission of a new drug application for Prevora in the U.S.
Prevora has been available through dental offices in Canada since 2007.
CHX is a leader in conducting randomized controlled clinical trials in
preventive dental care and in developing effective consumer awareness
campaigns to encourage the adoption of Prevora as a preventive treatment
in family dental offices.
SOURCE CHX TECHNOLOGIES INC.
For further information: For further information:
Ross Perry, CHX Technologies
Tel: (416) 233-3737 or email@example.com