Solriamfetol significantly improves wakefulness in patients with obstructive sleep apnea who suffer from excessive sleepiness, results from a phase 3 study show. At 150-mg and 300-mg doses, the drug had statistically significant effects on objective and subjective measures.In the trial, patients on various doses of solriamfetol had better improvements on the two primary outcomes of wakefulness and daytime sleepiness compared with those on placebo The researchers Kingman Strohl, MD, of University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine and associates reported these findings at CHEST, the annual meeting of the American College of Chest Physicians.
Untreated sleep apnea can lead to serious problems due to its effect on the state of wakefulness in these patients.Therefore there is a requirement for a drug which could increase wakefulness in patients with obstructive sleep apnea. In already available amphetamine-related drugs addiction liability is a concern.Only other approved wake-promoting drug modafinil specifically for excessive sleepiness associated with OSA works on a different wakefulness pathway from solriamfetol.
Solriamfetol, also known as JZP-110, is a selective dopamine-norepinephrine reuptake inhibitor whose neurotransmitter profile of solriamfetol is different than that of drugs currently on the market to treat excessive sleepiness, such as modafinil.The efficacy of JZP-110 for impaired wakefulness and excessive sleepiness was observed at 150-300 mg/day and as early as one week after initiating treatment.
Jazz Pharmaceuticals is in the process of submitting solriamfetol for FDA evaluation. If approved, the drug will add to the options available for narcolepsy patients. “All of the available drugs have some limitations. Some have more abuse liability than others. Some have more robust wake-promoting properties than others. We haven’t done any head-to-head comparisons, so I can’t tell you how we will stack up,” Philip Jochelson, MD, said in an interview. Dr. Jochelson is vice president of clinical development at Jazz Pharmaceuticals and presented the results of the study at a poster session at the annual meeting of the American Neurological Association. Solriamfetol IS under investigation for the treatment of excessive sleepiness associated with OSA, narcolepsy, hypersomnia, and renal failure.
The most common adverse events among the solriamfetol patients were headache (10.1%), nausea (7.9%), decreased appetite (7.6%), and anxiety (7%), and these side effects increased with dosage. The most common adverse events and discontinuation of therapy due to adverse events were most common in the 300-mg solriamfetol group.