Joint Pain Forum – News you can use!
ZARS Initiates Phase 3 Clinical Trial Of ThermoProfen For Osteoarthritis Treatment
July 30, 2007
ZARS commenced the first of two Phase 3 clinical trials of ThermoProfen
in patients with mild to moderate osteoarthritis (OA) of the knee.
The Company plans to conduct two, 12-week, three arm, double blind
Phase 3 efficacy trials within the United States in patients with mild
to moderate OA of the knee. These trials will be conducted with
ThermoProfen, a matrix transdermal ketoprofen patch with an integrated
CHADD (Controlled Heat-Assisted Drug Delivery) unit. In each of the two
Phase 3 trials, 1500 patients will be randomized to one of three
treatment groups to receive: ThermoProfen, a ketoprofen control (a
patch with drug but no heat), or a heat control (a patch with heat but
The primary measure of efficacy will be the patient's report of average
pain intensity over the last 24 hours at Week 12. A predefined interim
analysis will be conducted after approximately 100 patients in each
group have completed the first study to determine if the projected
number of 500 patients in each of the three groups will be sufficient
to demonstrate a statistically significant difference in the primary
efficacy endpoint. ThermoProfen is expected to provide localized pain
relief with lower systemic levels than oral administration of
ketoprofen, and is expected to reduce the frequency of adverse effects
of oral ketoprofen and other oral NSAIDs.
"We believe that ThermoProfen could address the significant medical
need of patients suffering from OA while at the same time lowering the
risk of the negative side effects associated with chronic NSAID use,"
said Robert Lippert, President and Chief Executive Officer, ZARS.
"These trials, assuming that they are successful, are intended to
provide the pivotal data to support global marketing applications for
In addition to the two efficacy trials, an open-label
safety trial will be conducted. In the safety trial, patients who
complete either of the two efficacy trials will be able to use one or
two ThermoProfen patches daily for up to one year. The Company also
plans to initiate a two-year preclinical dermal carcinogenicity study.
OA is a disease of the joints that causes erosion of
cartilage and leads to friction between bones. Based on data from IMS
Health, we estimate that 6.5 million people in the United States have
mild to moderate pain associated with OA of the knee. We believe that
the number of individuals with OA of the knee will increase due to the
growing U.S. population, shifting age demographics and additional
factors including obesity that can increase the prevalence of OA. The
two most common treatments for the pain associated with OA of the knee
are non-selective and COX-2 selective NSAIDs.
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