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AZD1940 was selected based on earlier data from a single dose study in man, in which it was identified as the highest well tolerated dose.
Ongoing post-operative pain (primary variable) and pain on jaw movement were assess on a visual analog scale (VAS, 0–100 mm) from 0 to 8 h postoperatively,
Deriving the area under the curve of ongoing pain (VAS AUC0–8 h), and also of pain on jaw movement (VASJM AUC0–8 h).
The time to requesting rescue medication (acetaminophen) was also record.
Subjective cannabinoid effects were assess by the visual analog mood scale (VAMS).
Results in total, 151 patients were randomize to AZD1940 (n = 61), placebo (n = 59) or naproxen (n = 31).
There is no statistically significant difference in pain VAS AUC0–8 h or in VASJM AUC0–8 h between AZD1940 and placebo.
Naproxen significantly reduced both pain VAS AUC0–8 h and VASJM AUC0–8 h as compared with placebo (p < 0.0001 for both).
Significantly fewer patients on naproxen request rescue medication and the duration of time to rescue is greater compared to placebo
whereas there were no significant differences between AZD1940 and placebo in these outcome variables.
Statistically significant increases in VAMS items “sedates” and “high” is observe after AZD1940 compare to placebo.
As a result the increases in VAMS were numerically small compare with previous findings with a centrally acting cannabinoid.
The most commonly observed adverse events (AE) on treatment with AZD1940 were postural dizziness (80% of subjects)
nausea (26%), hypotension (21%) and headache (13%), most AE being mild to moderate.
Conclusion The CB1/CB2 receptor agonist AZD1940 did not reduce post-operative pain after lower third molar surgical removal
at doses exerting subjective cannabinoid effects.