Posted by PeterMartin on March 21, 2019, at 12:09:33
The FDA approved Jazz Pharma's new Narcolepsy drug Sunosi (solriamfetol) today. It's a novel medication kinda like Provigil/Nuvigil were before it although it's different than those as well. Per wikipedia it is derived from phenylalanine (which sadly means it'd probably be unwise to take if you take an MAOi as I do)
Article (and last part is from Wikipedia):
https://www.empr.com/home/news/sunosi-approved-for-excessive-daytime-sleepiness-with-narcolepsy-osa/Sunosi is a first-in-class dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI). The approval was supported by data from the phase 3 TONES (Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness) program, which included 4 randomized placebo-controlled studies. In the studies, treatment with Sunosi demonstrated superiority over placebo. Over 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA have been evaluated.
At week 12, the Sunosi 150mg dose in narcolepsy patients and all doses in OSA patients led to improvements in wakefulness vs placebo as seen in test sessions approximately 1 to 9 hours post-dose of the maintenance of wakefulness test (MWT). Patients taking Sunosi 75mg and 150mg doses also exhibited improvement in their overall clinical condition at week 12, as measured by the Patient Global Impression Change (PGIc) scale. Moreover, the clinical effect of Sunosi was maintained compared with placebo after 6 months of use.
Headache, nausea, decreased appetite, and anxiety were the most common adverse reactions reported in the narcolepsy and OSA patient populations.
Sunosi will be available as 75mg (functionally scored) and 150mg tablets in 30- and 100-count bottles following final scheduling by the Drug Enforcement Administration (DEA), which usually occurs within 90 days of FDA approval.
The drug was discovered by a subsidiary of SK Group, which licensed rights outside of 11 countries in Asia to Aerial Pharma in 2011.[2]
Aerial ran two Phase II trials of the drug in narcolepsy[3] before selling the license to solriamfetol to Jazz in 2014; Jazz 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.[2][4]
Solriamfetol had also been tested in animal models of depression, but as of 2017 that work had not been advanced to clinical trials.[5] During development it has been called SKL-N05, ADX-N05, ARL-N05, and JZP-110.[6]
In March 2018 the FDA accepted SK's and Jazz' NDA for use of solriamfetol to treat excessive sleepiness in people with narcolepsy or obstructuve sleep apnea; the drug has an orphan designation for narcolepsy.[2][6]
poster:PeterMartin
thread:1103656
URL: http://www.dr-bob.org/babble/20190206/msgs/1103656.html