Source: Brain  |  Posted 4 years ago

By Jerry Ingram

NEW ORLEANS, LA -- February 14, 2007 -- Tapentadol HCI might be effective in providing pain relief for patients undergoing molar surgery, suggest preliminary results from a phase 2 study.

Shaun Comfort, MD, associate director for development, Johnson and Johnson, Rockville, Maryland, speaking on behalf of the study's authors, discussed the findings here on February 9[^]th[] at the American Academy of Pain Medicine 23[^]rd[] Annual Meeting (AAPM).

"This study shows quite good efficacy compared to 60 mg of morphine," said Dr. Comfort. "It looks like an interesting compound with a dual mechanism of action with an opioid-like effect. In addition, it has a norepinephrine reuptake inhibition."

For this randomized, double-blind, double-dummy, placebo-controlled trial, investigators enrolled 400 adults diagnosed with moderate-to-severe dental pain after a third surgical removal of molars. Clinicians randomized patients within 6 hours following the surgery, assigning patients to tapentadol HCl (25, 50, 75, 100, or 200 mg), morphine sulfate 60 mg, ibuprofen 400 mg, or placebo.

They set as the primary endpoint the efficacy of total pain relief over 8 hours after patients received their medications. They implemented a 5-point verbal rating schedule to assess relief from pain compared with baseline.

The research team found that patients receiving tapentadol HCI 75 mg, tapentadol 100 mg, and 200 mg reported more favorable scores when compared with placebo ([]P[] < .001, []P[] < .05, and []P[] < .001, respectively).

Additionally, total pain relief after 4 hours was higher with onset of action appearing more rapidly for patients in the tapentadol HCI 200-mg group compared with those in the morphine sulfate 60-mg group. The mean level of pain relief obtained with morphine sulfate 60 mg was between that achieved with tapentadol HCl 100 mg and 200 mg, they stated.

Based on these preliminary findings, the researchers suggested that tapentadol HCI may provide effective and well-tolerated relief of moderate-to-severe dental pain following third molar surgery.

"We're excited about the results so far and we hope that it will be out in a few years," concluded Dr. Comfort.

[Presentation title: Efficacy of a Single Dose of Tapentadol HCl for Analgesia After Third Molar Surgery. Poster 139]