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Biotech Stocks Facing FDA Decision In November 2020

Supernus Pharmaceuticals
Supernus Pharmaceuticals

The FDA decision on Supernus Pharmaceuticals Inc.’s (SUPN) SPN-812, proposed for the treatment of children and adolescents with attention deficit hyperactivity disorder, is expected on November 8, 2020.

SPN-812 is a novel non-stimulant and its active ingredient is Viloxazine hydrochloride which was previously marketed in Europe for many years as an antidepressant.

If approved, SPN-812 will compete with Eli Lilly’s (LLY) Strattera, the first non-stimulant treatment for ADHD. Strattera, which was approved in 2002, went generic in May 2017, when several generic versions of the drug secured the FDA nod simultaneously.

While stimulant drugs are the most commonly prescribed medications for the treatment of ADHD and are considered first-line treatments, non-stimulant drugs are usually considered second-line or third-line treatments and they provide a useful alternative for children who do not tolerate stimulants well.

SUPN closed Friday’s (Oct.23, 2020) trading at $20.09, down 0.20%.