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here’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.

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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, 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?

Adzenys
Adzenys XR-ODT extended-release tablets NEOS

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.)

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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?”

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  • Psychiatrists think Adzenys “could be yet another gateway into ADHD drug abuse”?

    *****ADHD MEDICATIONS SIGNIFICANTLY REDUCE SUBSTANCE ABUSE RATES IN ADULTHOOD****** This is from a study with a sample size of 3 MILLION subjects. How on earth would someone taking a medication end up abusing the medication, if the medication prevents them from abusing substances to begin with? This isn’t a “controversy” between psychiatrists. This is a disagreement between ignorant and competent ones.

    ADHD medication tied to lower risk for alcohol, drug abuse in teens and adults
    http://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.2017.16060686
    https://www.sciencedaily.com/releases/2017/07/170712201249.htm
    The risk of substance use problems during periods of medication use was 35 percent lower in men and 31 percent lower in women in the study. The results, based upon nearly 3 million people with ADHD in the United States, are reported in the American Journal of Psychiatry.

    Does Childhood Treatment of ADHD With Stimulant Medication Affect Substance Abuse in Adulthood?
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2667111/
    …An interesting finding of the Biederman et al. study is the failure to confirm the prior claim that treatment with stimulants markedly reduced the risk for substance abuse (4). …
    In these studies of the long-term outcomes of individuals with ADHD, the evidence that current clinical practice does not increase later substance use or abuse is comforting, but the failure to document that childhood treatment with stimulant medication decreases the high risk of substance abuse in adulthood is distressing.

  • Hi everyone, I currently take this medication but please everyone who is currently taking this or is planning on taking this, DO NOT CHEW THIS MEDICATION!!! It is mean to dissolve on the tongue to work properly. Also, please DO NOT dissolve this into a glass of water or juice. This is not how the medication is supposed to be taken, and dissolving it on your tongue is the way it is meant to be taken and work most effectively for its technology. It is also not mean to be split or cut!!!!!

  • My granddaughter is on Vyvanse 50mg. She’s 12 years old I have to open the pill and put it in juice. Is there a gummy for ADHD r chewable she 176 5″6 feet

  • My child truly needs the assistance of medication though I have ALWAYS been against the idea. He cannot and will not take liquids or swallow pills so this IS my only option to help him. He has only taken this for a month and his abilities to focus have improved greatly. His grades are rising. He needs this as much as I wish he did not. All meds can be used inappropriately and yes this could be used that way, but there IS aneed and not just a want.

    • Pamela, my son is 10 and has been on meds since age 4. How is this medication different? Our dr just gave us some info about it yesterday. How is appetite suppression? I heard it may not be as severe with this medication. My son truly does need his meds to function and focus at school too. Thanks.

    • Dana, this actually has not affected his appetite! He has always been a very picky eater and other drugs have caused him problems. (When I could get them in him) He lost alot of weight. He is now gaining slowly!

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