Solriamfetol


Solriamfetol, sold under the brand name Sunosi, is a medication used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea.
Common side effects include headache, nausea, anxiety, and trouble sleeping. It is a norepinephrine–dopamine reuptake inhibitor. It is derived from d-phenylalanine and its chemical name is -2-amino-3-phenylpropylcarbamate hydrochloride.
The drug was discovered by a subsidiary of SK Group, which licensed rights outside of 11 countries in Asia to Aerial Pharma in 2011.

History

The drug was discovered by a subsidiary of SK Group, which licensed rights outside of 11 countries in Asia to Aerial Pharma in 2011. Aerial ran two Phase II trials of the drug in narcolepsy before selling the license to solriamfetol to Jazz in 2014; Jazz Pharmaceuticals paid Aerial $125 million up front and will pay Aerial and SK up to $272 million in milestone payments, and will pay double-digit royalties to SK.
In 2019, solriamfetol was approved in the United States to improve wakefulness in adults with narcolepsy or obstructive sleep apnea. It was granted orphan drug designation.
The U.S. Food and Drug Administration approved solriamfetol based primarily on evidence from five clinical trials of 622 patients with narcolepsy or obstructive sleep apnea. The trials were conducted in Canada, Europe, and the United States.

Names

During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.