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The drug Oxytrex®
is superior to oxycodone in providing osteoarthritis patients
longer lasting pain relief and better physical function, according
to the results of a phase II study released October 16
Oxytrex is
a small molecule drug for treating severe chronic pain that is
currently in Phase III trials. Oxycodone is an opiate painkiller.
The
trial involved 350 patients at 30 clinical centers across the country. All of
the participants suffered from moderate to severe chronic pain due to advanced
osteoarthritis of the hip or knee. Patients were randomly assigned to one of four
treatment groups: placebo, oxycodone or two different strengths of Oxytrex.
On a scale
of 0 (no pain) to 10 (worst imaginable pain), all of the study
participants had average pain scores ranging from 7.4 to 7.7 at
the beginning of the study. The two groups taking Oxytrex reported
41 percent and 26 percent improvement in their pain scores, compared
to 21 percent and 24 percent, respectively, for the placebo and
oxycodone groups.
The
researchers also found Oxytrex to be well tolerated throughout the study with
no reports of serious adverse events. The prevalence of these side effects was
statistically indistinguishable among the active treatment groups. Oxytrex
also was reported to be superior to oxycodone according to a widely used scale,
the WOMAC Osteoarthritis Index, which measures changes in physical function, such
as joint stiffness and range of motion in osteoarthritis patients. "These
clinical data showcase the ability of Oxytrex to outperform oxycodone in a multi-dose,
chronic model of pain," said Remi Barbier, president and chief executive
officer of Pain Therapeutics, Inc., which is developing Oxytrex. Other
sources: Pain Therapeutics, Inc.
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