Conference Coverage
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BALTIMORE—Solriamfetol effectively reduces excessive sleepiness in patients with narcolepsy, regardless of whether they also have cataplexy, according to research described at the 32nd Annual Meeting of the Associated Professional Sleep Societies. The drug also improves work productivity and reduces activity impairment outside of work in this population. The molecule’s efficacy is maintained during one year of treatment in patients with narcolepsy or obstructive sleep apnea (OSA), and solriamfetol generally is safe and well tolerated, said the researchers.
A Reanalysis of Phase III Data
Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor that promoted wakefulness in patients with narcolepsy in a large phase III trial. Investigators presented the results of three new studies of solriamfetol during the meeting. In the first study, Yves Dauvilliers, MD, PhD, a neurologist at Gui-de-Chauliac Hospital in Montpellier, France, and colleagues reanalyzed the data from the phase III trial to assess the drug’s efficacy in subgroups of patients with and without cataplexy.
Yves Dauvilliers, MD, PhD
Eligible patients were adults with type 1 or type 2 narcolepsy, a baseline Maintenance of Wakefulness Test (MWT) result of less than 25 minutes, and an Epworth Sleepiness Scale (ESS) score of 10 or greater. Patients were randomized in equal groups to placebo or a 75-mg, 150-mg, or 300-mg dose of solriamfetol for 12 weeks. The primary end points were the change from baseline to week 12 in sleep latency on the MWT, the ESS, and the Patient Global Impression of Change (PGI-C) scale.
Of the 231 patients included in the analysis, 117 had cataplexy. The investigators observed no key baseline differences in daytime sleepiness between participants with cataplexy and those without. Participants’ mean age was approximately 36, 66% of participants were female, and mean BMI was about 28. Average sleep latency on MWT was 7.6 minutes, and mean ESS was about 17.
Among participants with cataplexy, the mean change in sleep latency at Week 12 was 1.8 minutes in the placebo group, 3.4 minutes in the 75-mg group, 7.9 minutes in the 150-mg group, and 10.7 minutes in the 300-mg group. Among participants without cataplexy, the mean change was 2.6 minutes in the placebo group, 6.0 minutes in the 75-mg group, 11.6 minutes in the 150-mg group, and 13.8 minutes in the 300-mg group.
The mean decrease in ESS score among patients with cataplexy at Week 12 was 1.8 points among controls, 3.1 points in the 75-mg group, 5.6 points in the 150-mg group, and 6.3 points in the 300-mg group. Among patients without cataplexy, the mean decrease was 1.5 points in controls, 4.5 points in the 75-mg group, 5.2 points in the 150-mg group, and 6.4 points in the 300-mg group.
A significantly greater percentage of patients in the 150-mg and 300-mg groups had improvement in PGI-C at Week 12, compared with controls, regardless of whether they had cataplexy. Among patients without cataplexy, a significantly greater percentage of those who received 75 mg of solriamfetol also had improvement in PGI-C at Week 12, compared with controls.