Harmony Biosciences published two clinical studies on WAKIX® (pitolisant). These studies evaluated the long-term safety and efficacy of the medication, as well as its human abuse potential.

The study confirms the efficacy of pitolisant for improving daytime sleepiness over a 12-month period. The improvement in excessive daytime sleepiness was seen during the first month of treatment, increased up to six months, and was maintained until the end of the 12-month period. This time period to achieve the maximum benefit on sleepiness (up to 6 months) is similar to that observed in trials of sodium oxybate. The Epworth Sleepiness Scale improvement was in the same range as that found in these trials of sodium oxybate as well as in a long-term trial with modafinil.

The Harmony III Study looked at the long-term safety and efficacy of pitolisant on narcolepsy. Patients (75 with cataplexy) received pitolisant, for the first time in 73 of them. Sixty-eight patients (51 with cataplexy) completed the 12-month treatment. Common treatment-emergent adverse events were headache (11.8% of patients), insomnia (8.8%), weight gain (7.8%), anxiety (6.9%), depressive symptoms (4.9%), and nausea (4.9%). Seven patients had a serious adverse effect, unrelated to pitolisant except for a possibly related miscarriage. One-third of patients stopped pitolisant, mostly (19.6%) for insufficient benefit. Complete and partial cataplexy, hallucinations, sleep paralysis, and sleep attacks were reduced by 76%, 65%, 54%, 63%, and 27%, respectively.

More information can be found on this press release from Haromy Bioscience.