There’s a new, candy-flavored amphetamine on the market.
Adzenys, as the chewable, fruity medication is called, packs the punch of Adderall and is geared toward children with attention deficit hyperactivity disorder.
The drug hit the market last week and is already stirring controversy: Some psychiatrists worry that Adzenys will accelerate a trend toward overmedicating kids — and could be yet another gateway into ADHD drug abuse.
Presenting amphetamines in a tasty, convenient package is “a recipe for people to request it and then sell it,” said Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist in Napa, Calif.
“I’m not a big fan of controlled substances that come in forms that can be easily abused — and certainly a chewable drug falls into that category,” Gnanadesikan said.
Adzenys, an extended-release amphetamine, was approved by the Food and Drug Administration in January for patients 6 years and older. It comes in six dose strengths. The Dallas company behind the drug, Neos Therapeutics (NEOS), began ramping up commercial efforts this week in order to get “ahead of back-to-school season,” CEO Vipin Garg said. “We’re launching now at full speed.”
The company has 125 sales reps across the United States, and they’re having “no problem” getting appointments with doctors interested in prescribing this new formulation, Garg said. The product is winning support from doctors who see it as a convenient way to give children the drugs they need. And analysts are generally bullish about Neos’s prospects.
A booming market for ADHD drugs
There’s a very real population of children and adults whose lives are vastly improved by medications like Adderall and Ritalin, which stimulate the central nervous system and affect chemicals in the brain associated with impulse control. But the line between need and want is increasingly blurry.
About 75 percent of children diagnosed with ADHD are on medication — a statistic that concerns many psychiatrists. (The Centers for Disease Control and Prevention advises parents to try behavior therapy before pharmaceutical intervention.)
In teens and adults, there’s also rampant misuse: These stimulants are commonly used as party drugs and as performance enhancement aids; some students say the meds help them focus and improve their grades.
All that adds up to a booming market. Sales for ADHD medications were at $4.7 billion in 2006, had nearly tripled to $12.7 billion by last year, and are projected to grow to $17.5 billion by 2020, according to a 2015 report from market research firm IBISWorld.
Adzenys is the first extended-release drug for ADHD that dissolves in the mouth (though a rival drug, Shire’s Vyvanse, comes in capsules that can be opened so the medication can be sprinkled over food). It’s also the first to come in a blister pack, not a pill bottle — making it exceptionally portable and convenient.
Garg says the new, quick-dissolving formulation will help harried mothers get their kids medicated faster before school. It could also be useful for the adult ADHD population, he said: If they forget to take their pill with breakfast, they could just pop a tablet on the way to work. He sees the dissolving tabs as part of a broader trend to making medications and supplements of all types more pleasant to take.
“You go to a pharmacy, and everything is in gummy bear format,” Garg said. “Why would that be the case if there wasn’t a need for this?”
A convenience for harried moms — or for dealers?
Some psychiatrists see no reason to worry about Adzenys. Those who abuse the drug won’t care if it comes in the form of a nice-tasting chewable or a traditional pill: They’re only focused on the effects of the drug, said Dr. Ben Biermann, an assistant professor of psychiatry at University of Michigan’s C.S. Mott Children’s Hospital.
“There’s nothing revolutionary about this drug,” Biermann said. “It’s simply another delivery mechanism for a medication that already exists and has widespread use.”
And for kids who balk at swallowing pills, Adzenys could be a boon, said Dr. Greg Mattingly, a child psychiatrist who teaches pharmacology at the Washington University School of Medicine.
(Mattingly, who is a board member of the American Professional Society of ADHD and Related Disorders, said he has no financial stake in Neos, but did present research on the drug at this week’s American Psychiatric Association meeting in Atlanta.)
Just this week, Mattingly prescribed Adzenys for the first time — to a 9-year-old boy who had been taking ADHD meds for some time. The child hated the liquid formulation and had trouble swallowing pills, so the family felt the chewable tabs offered new hope, he said.
Still, for those who believe ADHD is wildly overdiagnosed and overmedicated, the idea of making a drug more tasty and convenient is jarring.
It’s a move that sanctions “an orally disintegrating amphetamine for kids by the morally disintegrating FDA,” said Dr. Alexander Papp, an adult psychiatrist affiliated with University of California, San Diego.
“What’s next?” Papp scoffed. “Gummy bears?”