Conference Coverage
JZP-110 May Have Low Potential for Abuse
DENVER—The abuse potential of the investigational drug JZP-110 may be similar to or lower than that of the Schedule IV stimulant...
No New Safety Concerns Emerge
The safety profile of solriamfetol in these studies was similar in participants with and without cataplexy and was consistent with that indicated by previous trials. The most common treatment-emergent adverse events in the phase III trial that Drs. Dauvilliers and Emsellem analyzed were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, diarrhea, and anxiety. The rate of adverse events increased with increasing dose. More participants in the solriamfetol group discontinued the trial, compared with the placebo group. Solriamfetol did not affect BMI. Safety results were similar in Dr. Malhotra’s trial. Solriamfetol had “a durable effect without major side effects,” he said.
Jazz Pharmaceuticals, which is headquartered in Dublin, is developing solriamfetol and sponsored all three studies. The company filed a new drug application for solriamfetol with the FDA in March and expects a regulatory decision in late December.
—Erik Greb
Suggested Reading
Bogan RK, Feldman N, Emsellem HA, et al. Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. Sleep Med. 2015;16(9):1102-1108.
Ruoff C, Bogan RK, Emsellem H, et al. Evaluation of the effect of JZP-110 in patients with narcolepsy assessed using the Maintenance of Wakefulness Test censored to 20 minutes. Sleep Med. 2017;35:12-16.
Scrima L, Emsellem HA, Becker PM, et al. Identifying clinically important difference on the Epworth Sleepiness Scale: results from a narcolepsy clinical trial of JZP-110. Sleep Med. 2017;38:108-112.