NDA for a drug I worked on a decade ago is accepted by FDA
Wow. I didn't see this one coming. A long time ago Sepracor (now Sunovion) was working on a whole series of CNS drugs with an eye towards targeting depression, ADHD and restless leg syndrome. Sepracor was an amazing place to work at the time. With a pretty full pipeline we used to juggle projects and priorities quite a bit, so at various times I was the quality representative for just about all of them for a year or two...sometimes twice. While I knew at least one was still of interest, it wasn't this one so I was surprised by an article stating "The U.S. Food and Drug Administration (FDA) has accepted for review Sunovion Pharmaceuticals Inc.'s New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents, and adults."
(source: https://www.pharmpro.com/news/2017/11/fda-accepts-nda-review-adhd-treatment-all-age-categories)
Now, Dasotraline was an unfamiliar name, but a couple of quick google searches for chemical structures and it was clear this is an old friend back from the dead...or at least the back burner. There are a lot of hurdles for CNS drugs in these categories and the expertise brought by Sunovion employees who brought us Latuda no doubt contributed to this milestone. Best wishes for success Dasotraline!
