A new drug, solriamfetol (75, 150, or 300 mg) improved
wakefulness on the Maintenance of Wakefulness Test (MWT) and reduced excessive
sleepiness on the Epworth Sleepiness Scale (ESS) over a 12-week treatment
period when compared with placebo in patients with narcolepsy published in the
March 2019 issue of Annals of Neurology.
These improvements were observed in the first week of the
study itself and were maintained for the 12 weeks of the study indicating that
there was no apparent tolerance to the drug over the study period.
Solriamfetol showed dose‐dependent
efficacy that was significantly superior to placebo on both coprimary endpoints
at the 150 and 300 mg doses. Solriamfetol 75 mg dose showed greater improvement
than placebo on the ESS but not on the MWT.
What is it? Solriamfetol is a selective dopamine and
norepinephrine reuptake inhibitor with wake-promoting effects.
Side effects: Headache, nausea,
loss of appetite, nasopharyngitis, dry
mouth and anxiety
Regulatory status: Solriamfetol has been
FDA approved to treat excessive daytime sleepiness in adults with narcolepsy or
obstructive sleep apnea (OSA). Approved doses are 75 mg and 150 mg for patients
with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA.
It is to be administered once-daily.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
No comments:
Post a Comment