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Human Abuse Potential Study
The assessment of the abuse potential of WAKIX included a human abuse potential study in adults1
- 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, pitolisant 213.6 mg, phentermine HCl 60 mg (active control), and placebo
- The primary endpoint was the mean maximum effect (Emax) for drug liking “at this moment” assessed on a 100-point visual analog scale (VAS) where 0 = strong disliking and 100 = strong liking1
- 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)
- Primary endpoint: The mean Emax for drug liking “at this moment” on VAS 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
- In this study, WAKIX demonstrated an abuse potential profile similar to placebo1
- WAKIX was similar to placebo on drug liking
- No signals from experimental measures suggestive of abuse