Abstract
Bicifadine is a novel non-narcotic analgesic, with selective inhibition of norepinephrine and serotonin uptake and NMDA antagonism. In previous studies, bicifadine produced effective relief of acute pain arising in various pain models, including dental surgery. Replicate previous findings and demonstrate the efficacy and safety of a single oral dose of bicifadine, at three dose levels (200,400,600 mg) compared with placebo, and tramadol 100mg compared with placebo in moderate to severe postoperative dental pain. Subjects (n=540) undergoing the surgical removal of impacted third molars were randomly administered one of the five treatments. Pain intensity, relief and AEs were evaluated for 12 hours. Bicifadine, in a dose dependent fashion, produced a significant (p<0.0001) overall effect in summary measures of efficacy (SPRID, TOTPAR,SPID) as compared to placebo. Time-effect analyses indicated that bicifadine elicited significant (p<0.05) time-related pain relief at all doses.. Significant analgesic effects of bicifadine occurred in 1-hour and were sustained for the12-hour period. The maximal analgesic scores for 400 and 600mg of bicifadine were comparable to those for tramadol. Both tramadol and bicifadine were safe and relatively well tolerated without any SAEs. The most frequently reported AEs were nausea and emesis. Overall, bicifadine was associated with a lower likelihood of treatment-emergent nausea and emesis than tramadol. The highest proportion of AEs were seen at the 600mg dose. These findings confirm previous results and suggest that bicifadine may represent a new class of analgesic, which offers a fast-acting and safe treatment of pain, without the abuse, tolerance, and addiction liability of narcotic analgesics.
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