|The following article is part of conference coverage from the 2018 American Academy of Neurology Annual Meeting in Los Angeles, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2018.|
LOS ANGELES – A selective dopamine and norepinephrine reuptake inhibitor was associated with significant improvements in wakefulness and may reduce daytime sleepiness in patients with narcolepsy types 1 and 2. Data from the phase 3 placebo-controlled trial of solriamfetol were shared at the 2018 American Academy of Neurology Annual Meeting, April 21-27 in Los Angeles.
The 12-week, randomized, double-blind, parallel-group study included 236 patients with narcolepsy with or without cataplexy (67.2% female; 80.2% white). Patients were randomly assigned to receive solriamfetol 75 mg, 150 mg, or 300 mg or placebo for 12 weeks. Patients were required to have a mean sleep latency <25 minutes on the Maintenance of Wakefulness Test (MWT) and an Epworth Sleepiness Scale (ESS) score ≥10, as well as nightly sleep time ≥6 hours. Patients were not included if they were taking medications that promote excessive sleepiness or cataplexy, worked during nighttime hours or variable shift work, or had a diagnosis besides narcolepsy that caused excessive sleepiness.
Among the participants, baseline ESS score was 17.2, and mean baseline MWT was 7.5 minutes. At week 12, treatment with solriamfetol was associated with a statistically significant increase in MWT for both the 150-mg and 300-mg doses (P <.0001; least squares [LS] mean change = 12.3 minutes for 300 mg; 9.8 minutes for 150 mg; 4.7 minutes for 75 mg; and 2.1 minutes for placebo). The treatment group also saw a statistically significant decrease in ESS score at 12 weeks (P <.0001 for 150 mg and 300 mg; P <.05 for 75 mg; LS mean change = -6.4 for 300 mg; -5.4 for 150 mg; -3.8 for 75 mg; and -1.6 for placebo). Notably, significant improvement was seen at week 1 across all 3 dosing groups; however, this change was not maintained in the 75-mg group.
The most common treatment-emergent adverse events were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. One patient reported 2 serious adverse events; however, those were deemed unrelated to the study drug, and the patient maintained his participation in the study. Overall, discontinuations were more frequent in the 150-mg and 300-mg groups vs the 75-mg and placebo groups.
The data support solriamfetol as safe, tolerable, and associated with a statistically significant improvement in wakefulness and reduced excessive sleepiness in patients with narcolepsy types 1 and 2.
“There is a likelihood that because of the robustness of the effects and the safety profile [of solriamfetol], it’s likely that it will improve excessive sleepiness from a whole variety of disorders, including Parkinson disease,” lead investigator Michael Thorpy, MD, said during his presentation.
Disclosures: This study was supported by Jazz Pharmaceuticals.
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Thorpy MJ, Shapiro C, Mayer G, et al. A randomized, placebo-controlled, phase 3 study of the safety and efficacy of solriamfetol (JZP-110) for the treatment of excessive sleepiness in participants with narcolepsy types 1 and 2 (NT1/2). Presented at: 2018 American Academy of Neurology Annual Meeting. April 21-27, 2018; Los Angeles, CA.