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 profits.
A similar shortage happened this year in Wisconsin when a change in policy aimed at saving the state money meant only Adderall would be covered under Medicaid. It seems that these companies — and the state that protects them — don’t care about your unmet needs, just the market’s.
KemPharm is also working on new drugs specifically to “target the large and growing population of adult ADHD patients” that make up “the largest segment of the ADHD market.” One tentatively titled KP484 is made of the same compound in Azstaryz; they’re also working on “a series of prodrugs of amphetamine”.
In a hilariously dark twist of irony, KemPharm is planning to use their stimulant prodrug SDX to treat Stimulant Use Disorder, “a potential first-ever therapeutic treatment for SUD” — developing stimulants and then using those same stimulants to treat stimulant abuse.
The newest non-stimulant, Qelbree (or viloxazine) has been approved for kids aged 6–17, and Supernus is trying to get approval for adults. It’s a norepinephrine reuptake inhibitor, but they think it may act on serotonin, too, and despite the claim that it’s new and exciting, it’s been used in Europe as an antidepressant for decades already.
David Rettew, M.D., the medical director of the Child and Adolescent and Families Division of the Vermont Department of Mental Health, was quoted by the American Psychiatric Association saying that Qelbree “has many of the same warnings [as antidepressants], such as the potential for increased suicidal thoughts and activation of mania. Some of the blood pressure and pulse increases have also been found with antidepressants that have norepinephrine reuptake properties such as venlafaxine,” aka Effexor.
Prescribing antidepressants to young children resulted in a massive increase in manic episodes and suicidality, as Robert Whitaker reported extensively in his book Anatomy of an Epidemic. Many children who received a diagnosis of “Childhood Bipolar Disorder” — child psychiatrist and pharma shill Dr. Joseph Biederman’s invention that resulted in “a 40-fold increase” in diagnoses — had previously been prescribed antidepressants or stimulants.
Qelbree might be a new name, but it carries the same risks, just like Azstaryz and all its familiar side effects. We’re going to see more new faces on old drugs in the coming years, as the ADHD market has been forecast to be worth $24.9 billion by 2025. That’s a lot of money on the table, and you can bet these companies are going to use whatever marketing tricks they can to grab it.