K. Gottesdiener et al., Efficacy and tolerability of the specific cyclooxygenase-2 inhibitor DFP compared with naproxen sodium in patients with postoperative dental pain, CLIN THER, 21(8), 1999, pp. 1301-1312
DFP [3-(2-propyloxy)-(4-methyl-sulfonyl-phenyl)-(5 5-dimethyl)-furanone] is
a highly specific cyclooxygenase-2 inhibitor (>2500-fold selective in tran
sfected Chinese hamster ovary cell assays) that has demonstrated efficacy i
n preclinical models of pain and inflammation. The present single-dose, ran
domized, double-masked, double-dummy, placebo-controlled, parallel-group st
udy was undertaken to compare DFP 5, 25, and 50 mg with naproxen sodium 550
mg and with placebo in 196 patients (mean age, 25.8 years; 187 [95.4%] mal
es) who experienced moderate-to-severe pain after surgical removal of great
er than or equal to 2 third molars. Overall analgesic effect, duration of e
ffect, time to onset of analgesic effect, peak analgesic effect, and tolera
bility were assessed over a 24-hour postdose period. Both DFP 25 and 50 mg,
as well as the active comparator, naproxen sodium 550 mg, were significant
ly more effective than placebo. The onset of analgesic effect in the DFP 25
-mg, DFP 50-mg, and naproxen sodium 550-mg groups did not differ significan
tly. DFP was generally well tolerated in single doses up to 50 mg. DFP 50 m
g was efficacious in the treatment of postoperative dental pain and was ind
istinguishable from the active comparator, naproxen sodium 550 mg.