Jazz Pharmaceuticals has reported positive results from TONES 5 study, a Phase lll trial of solriamfetol for the treatment of excessive sleepiness (ES) in patients with narcolepsy or obstructive sleep apnea (OSA).
Findings of the open-label trial have showed solriamfetol’s long-term maintenance of efficacy and a tolerable safety profile in the enrolled patients.
As part of the trial, 643 patients, including 226 narcolepsy and 417 OSA, were given solriamfetol and included in the safety population, and 458 completed the study.
A total of 282 patients entered the two-week, placebo-controlled, randomised withdrawal (RW) phase, and 280 completed this phase, representing the modified intent-to-treat population.
At the end of the RW phase, patients who received solriamfetol showed improvement, while those who were switched to placebo remained worsened.
The primary endpoint in the RW phase included change in Epworth Sleepiness Scale (ESS) from beginning to end of the RW, while the secondary endpoints were patient and clinician global impression of change (PGI-C and CGI-C) respectively.
The trial had a two-week titration phase followed by a maintenance phase of up to 50 weeks.
Among the other results, the TONES 5 trial demonstrated long-term maintenance of efficacy during the open-label period for up to one year by sustained reductions in mean ESS scores and improvements on the PGI-C and CGI-C scales.
Jazz Pharmaceuticals Sleep and CNS Medicine senior vice-president Jed Black said: “If approved by the US Food and Drug Administration, solriamfetol would offer patients the first new chemical entity for the treatment of excessive sleepiness in narcolepsy and OSA in the US in nearly ten years.”
OSA is a prevalent disease where ES is a major presenting complaint in many cases.
ES in OSA is related to impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life.