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Human Abuse Potential Study
The assessment of the abuse potential of WAKIX included a human abuse potential study in adults1
- The primary endpoint in this study was the mean Emax for drug liking "at this moment"1
- Key secondary endpoints included mean Emax for global drug effects (ie, overall drug liking, take drug again) and positive drug effects (ie, good drug effects, high)
- Results showed that pitolisant had an abuse potential profile similar to that of placebo, with no findings suggestive of a risk of abuse1
- This was a randomized, double-blind, single-dose, 4-period crossover study in 38 healthy adult nondependent, recreational stimulant users1
- Each participant received all 4 treatments: pitolisant 35.6 mg (maxiumum recommendeded adult daily dose), pitolisant 213.6 mg, phentermine HCl 60 mg (active control), and placebo
- The primary endpoint was the mean Emax for drug liking “at this moment” assessed on a 100-point VAS, where 0 = strong disliking and 100 = strong liking, and was similar for WAKIX versus placebo1
- Study validity and sensitivity were confirmed by significant difference in Emax values between phentermine and placebo (P<0.0001)1
- For comparisons with pitolisant, statistical significance versus phentermine indicated a difference in drug liking, whereas statistical significance versus placebo indicated similarity in drug liking1
- Emax was significantly greater for phentermine versus pitolisant 35.6 mg and 213.6 mg (P<0.0001 for both), and was similar for pitolisant 35.6 mg and 213.6 mg compared with placebo (P<0.0001 and P<0.01, respectively)1
WAKIX is the first and only FDA-approved treatment for patients with narcolepsy that is not a controlled substance
Emax, maximum effect; VAS, visual analog scale.