Dimethaid launches Pennsaid(R) long-term safety and add-on therapy trials
TORONTO, March 23 /CNW/ - Pharmaceutical developer Dimethaid Research
Inc. (TSX: DMX) has begun enrolling patients in two postmarketing clinical
trials to confirm the long-term safety of Pennsaid(R) anti-arthritic lotion
and investigate the product's advantages in combination with a conventional
analgesic. A 12-week trial will look at the effects of using the topical drug
simultaneously with an oral nonsteroidal anti-inflammatory drug (NSAID). The
longer-term study will follow patients for up to 52 weeks. Health Canada
approved Pennsaid in March 2003 as a prescription treatment for knee
osteoarthritis symptoms.
Dr. Zev Shainhouse, Dimethaid's medical director, said, "Patients who
take an oral for disease in several joints might want to add Pennsaid, if a
knee was still painful. At the moment, we don't have data about add-on
therapy. Nor may we offer guidance to Canadian doctors who want to continue a
patient on Pennsaid for long periods of time."
The Journal of Rheumatology, a Canadian peer-reviewed publication, has
reported that up to 30 percent of osteoarthritis patients combine different
drugs when their primary medication isn't giving enough relief or their pain
suddenly flares up. Regulators discourage combining NSAIDs because of a
possible increase in the risk of side effects, but little research has been
done into add-on therapy.
"Real world, followup studies like this are important to building
additional credibility for the brand among doctors," said Danny Dean,
Dimethaid's director of national sales and marketing. "In this case, there's a
good possibility we could make the product available to an even wider range of
patients."
Investigators in the add-on trial will enrol approximately 750 patients
at up to 40 sites across Canada. The study will compare patients treated with
both Pennsaid and oral diclofenac to groups receiving different combinations
of topical and oral active drug or placebo. All patients must have primary
knee osteoarthritis, confirmed by X-ray, and experience with at least one oral
painkiller.
Efficacy will be evaluated using the Western Ontario & McMaster
Universities Osteoarthritis Index (WOMAC) scales for pain, stiffness and
physical function. Researchers will also track changes in Patient Global
Assessment (PGA) and Patient Overall Health Assessment (POHA), a new index
recently adapted by Dimethaid.
Patients in the add-on trial will have an opportunity to continue into
the extended safety study, which will include some 300 in total, providing
data on the incidence of adverse events, skin irritation, changes in ocular,
liver and kidney function, and other laboratory measurements.
An earlier postmarketing study has demonstrated that topically applied
Pennsaid is equivalent to the maximum daily dose of oral diclofenac in
relieving pain and improving physical function. |
