Posted by PeterMartin on October 19, 2018, at 2:17:35
The NRI Reboxetine/Edronax, which has been sold in Europe as an AD for years, looks likely to get approval in the USA as a narcolepsy drug. It's been given Orphan Drug designation and a company is pushing to get it approved. I find it interesting that they don't mention Reboxetine (aka AXS-12) has been sold in many countries for almost 2 decades:
Novel Narcolepsy Treatment Gets Orphan Drug Designation
AXS-12 is a highly selective norepinephrine reuptake inhibitor The Food and Drug Administration (FDA) has granted Orphan Drug designation to AXS-12 (reboxetine; Axsome Therapeutics), an oral medicine in development for the treatment of the symptoms of narcolepsy.
AXS-12 is a highly selective norepinephrine reuptake inhibitor. The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019.
"The designation is an important regulatory milestone in the development of AXS-12 for this debilitating condition," said Herriot Tabuteau, MD, CEO of Axsome. "We look forward to starting our planned Phase 2 trial of AXS-12 in patients with narcolepsy this quarter."
poster:PeterMartin
thread:1101422
URL: http://www.dr-bob.org/babble/20180728/msgs/1101422.html