The FDA approved two new ADHD drugs this year, and they’re being marketed as shiny new medical advances. It sounds exciting, but are these drugs really new and different?
Azstaryz is a stimulant developed by KemPharm, whose CEO called it “the first truly differentiated ADHD medication in years”, and Qelbree is “the first novel non-stimulant approval in a decade,” developed by Supernus Pharmaceuticals.
Azstaryz, which the company’s press release calls “a first-of-its-kind treatment” and “a true advance in ADHD medicine” is made up of 30% d-methylphenidate, or d-MPH, currently on the market as Focalin by Novartis (itself a version of methylphenidate, the OG ADHD drug, Ritalin).
70% of Azstaryz’s compound is a d-MPH prodrug called serdexmethylphenidate, or SDX. A“prodrug” is one that only becomes active when converted through chemical reactions in the body slowly throughout the day (in this case, SDX converts into d-MPH).
This new version of an old version of Ritalin, Azstaryz is supposed to last longer than other similar ADHD drugs, addressing “unmet needs in the market” as KemPharm claims. The side effects, though, are all the same as any other stimulant: decreased appetite, nausea, anxiety, trouble sleeping, mood swings, weight loss, and rapid heart rate.
The biggest difference in Azstarys seems to be the chemical compound, which they note on their website would offer “the potential for long-lived composition of matter patent protection.” Big words that mean: we could patent this specific combination of molecules and profit off of it for a very long time.
Pharma companies have been falling all over themselves for decades trying to develop slightly different molecules of the same drugs so they can own the patents, but patents don’t last forever, and when they lapse, generic versions enter the market and undercut these companies’ profits. This battle over profits affects patient care.
In 2011, there was panic over a stimulant shortage, and some blamed “addicts” who faked ADHD to get drugs that other people needed to use as medicine. What really happened was that pharma companies manufactured scarcity to make more…