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.

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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 (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?

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.)

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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  • I am now 60 it took 58 years to be dye nostalgia with A D h,D and I hate it always on the outside looking in never getting a answer with a problem I have.

  • My concern is that this medication is NOT CHEWABLE, and if the writers of this article can’t comprehend that, how do they expect children to?

  • 90% of UNMEDICATED ADHD kids get in trouble with the law. MOST ADHD KIDS HAVE CO MORBID CONDITIONS, one of which is most common is Sensory issues, including eating.
    My son has ADHD combined and is seven years old. I am not sure what doctors are RUSHING to medicate especially when the CDC and FDA are so concerned about medication that doctors most doctors I know have quit giving pain medication and stimulants to any new patients and are throwing people out of practices for next to no reason. I speak as a single mother of two children with ADHD. I screamed and yelled (figuratively) had both my children in Occupational Therapy where, when tested proved to be 36 months behind in fine and gross motor skills. My five year old after 9 months of OT could not write on a piece of paper and correctly form simple letters without tracing. She still has not obtained special placement and fine motor skills and is being pushed through kindergarten with good marks. I went so far as to reunite with a toxic husband bc he is good to the children and does not “act out to me” in front of them. I’ve screamed, cried and begged for help from the city, state and health community and only when my son went from academic honors to throwing desks has anyone listened.
    This medication works for my son and I’ve tried everything from a patch to a liquid. Both kids have been in therapy for emotional regulation and behavior since age two! I have a degree in Educational psychology and could write a book on all my self taught knowledge of ADHD and Autism. I’ve had both children evaluated by two or more school districts and outside Respected Pediatric Neurological teams and Psychiatrists. I’ve read every book, joined every support group and continue parent training on a weekly basis. I’ve given up any chance at a life of my own bc I want my children to be productive, non entitled citizens who can hold down jobs and deal with authority.
    This medication helps my child. Unfortunately, Vyvanse, which is even more easily administered also increased negative behavior to the point of punching me. My son gave me a black eye while I was trying to restrain him without hurting him from destroying our home and computer.
    I would like to thank the makers of this drug bc although it’s STILL difficult to get my child to take it, he does most of the time and it has helped him be able to focus so he can learn in school and therapy.
    I have not beat, neglected nor indulged my children into bad behavior. They’re paternal uncle behaved the same way while his mother ignored the behavior. He’s been arrested more times than I can name and was never medicated. Finally after going to PRISON he was forced into therapy by a judge and is now happier, healthier and more successful than my ex husband who has a college degree and made a perfect score on his SAT. In my opinion, my ex husband also has a form of ADHD but compensated with an extraordinarily high IQ. Today, he has no empathy or emotional regulation and that, my friends is ADHD. The ADHD population usually is very intelligent but lacks impulse control and emotional regulation. The disease is misnamed and very misunderstood and can make life a living hell if not addressed early with parent training and MEDICATION. There have always been and will always be those people who misuse pharmaceuticals bc addiction is another disease our nation refuses to give credence to bc of the way it looks, or doesn’t, the same with depression and anxiety.
    I thank God above for giving me something that I can get my child to take as he will not swallow a pill or drink the liquid (Ritalin/methylphenidate does not work as well as the Aderral compound, likely do to his body chemistry. ) My son is a different and more manageable child when on medication. This ensures the much needed therapy sinks in for both of us. I wish society would quit condemning and start listening, reading and understanding the human brain instead of constantly criticizing those of us who are fighting in the trenches.
    People, please think bf you judge and most especially bf you have children bc once they’re genetic make up is compiled and they are born, there’s nothing left to do but keep fighting the good fight, which is the MOST DIFFICULT thing I have ever done.
    Please tell your kids not to judge by leading by example and PLEASE PLEASE pass on the fact that it is not a requirement anymore to get married and have children to have a meaningful successful life.

    • Kudos to you for putting your experiences out there! I agree with what you are saying 200%. I myself am a young 52 yr old & have been on Adderall now for 5 yrs. It has literally transformed me & my life. Oh & get this! yrs ago I became addicted to Hydrocodone. WHY did I become addicted? Because like most people who become addicted it gave me ENERGY & I could actually focus & be a productive citizen 4 the 1st time in my adult life. I feel as if IF Drs would diagnose & TREAT people 4 Adhd and prescribe the proper meds I GUARANTEE you would see the opiate epidemic take a nose dive! A lot of us misdiagnosed folks TURN to forms of drugs BECAUSE we lack motivation & have no natural energy whatsoever!!! I don’t think i would’ve EVER became addicted 2 hydrocodone had I been put on Adderall to begin with. And guess what?!? I don’t abuse my meds NOR do I feel the urge or need to do so!!! Ugh! I get so frustrated! WHY can’t these Drs leave the mainstream naysayers OUT of the equation when diagnosing a pt? Do whats right not what OTHERS think is right or wrong! Oh & Drs. DO NOT diagnose someone based on ur personal beliefs or opinion! ADHD and or addiction is NOT a one size fits all like your “books” say!!! Oh & I know about a husband with no empathy mine had Narcissistic Personality Disorder and a form of ADHD & is the most TOXIC THING I have EVER dealt with. Hes one of Satan’s Spawns I tell ya! Well good luck to you all. I hope your journey down the ADHD road becomes easier to bear in the future. I know if the Drs would prescribe the medication that was MADE for ADHD a lot more folks out there would actually look forward to getting out of bed every day. People are always going to find something to abuse but when it comes to a med that is PROVEN to transform lives?!?!? PLZ DON’T BLAME THE ONES WHO ACTUALLY BENEFIT FROM THE DRUG & DEPRIVE US OR OUR KIDS OF A PRODUCTIVE LIFE!!!

  • Who cares what form the medication comes in …gummy, chewable etc. Any parent who has a child that needs this medicine and knows how hard it is at 7:00 am before school, when they’re having a complete meltdown over taste and texture and are irritable would agree that it doesn’t matter. It’s a blessing that this is finally available. It makes our entire lives easier and for my child takes the fear and negativity of having to take her medicine away. How in compassionate of people to think otherwise. Minors need prescriptions and I doubt a majority of parents don’t monitor the prescription and intake.

    • To withhold a medication from someone with add/adhd, narcolepsy or depression is just downright cruel. A few yrs back I baby sat a friends lil boy every day and let me just say if he wasn’t on his meds I refused to watch him. I wasn’t being mean or hateful in any way. I just could not control the lil guy. He would become violent & extreeemly sneaky. I mean this kids eyes even took on a different appearence when he was off his meds.( personally I think he needed to be evaluated for other disorders as well) but as far as his ADHD? ComPLETELY controlled while he was on his Adderall. On a different note I am so worried about all of the “changes” pertaining to ADHD meds because if I were to be taken off of MY adderall? Ooooh I don’t even want to think about it. Long story short(I hope) since the age of 6 I’ve struggled with Ocd ADHD & other mental disorders . Depression & Adhd being my main demons. None of my issues were never really addressed. I had/have a narcissistic mother & if it didn’t pertain to her or if it DID pertain to her as far as contributing to my illness she wouldn’t have anything to do with it. So I basically had to deal with my “mental well being” or there lack of pretty much on my own. Of course back then I didn’t know what was wrong with me I just knew I never felt normal. I felt like an outcast & an ingrate. So there I was with my mind going a million miles a second & wanting NEEDING to express myself & do something with the constant tug of war between my brain & my body. My brain was wanting to go go go but my body said no no no. Never knowing HOW to get my brain & my body/motivation on the same page I starting searching for anything that would or could get em on the same page. Well after having a tooth pulled I was given Vicodin and OMG there it was! The cure all! When I took it I wasn’t depressed, I could clean my house & actually had the motivation to do so! I was so productive that I felt like there was nothing I couldn’t do! And it was legal AND prescribed by my Dentist so that made it okay!(in my delusional eyes) so off I went hopping down the opiate trail. Doing what I could to continue to get it because there was no way in HELL I was going back to only existing. By God I was LIVING for the first time in my life and NOBODY was going to take that from me! Well of course they did take it and I’m glad to say that if I never see another opiate in this lifetime it’ll be too soon. Bottom line here is Drs. Need to listen to the mother’s who have children with ADHD & they need to listen to us adults who have it. If ur a recovering addict & seriously want to be a productive citizen & get ur ADHD under control? I’m not going to lie it’s going to hard but don’t give up. Stand firm when u are talking with a Dr . and assure them that u arent drug seeking. My dr knows everything about me & helps me in any way he can. U just have to be honest. It floors me how they “invent” all of these miracle working meds yet they don’t wanna give em too you. As far as getting “hooked” I say this if ur taking ur meds correctly & it really works or helps ur not going to want to abuse it because its doing what its supposed to do. If u are abusing ur meds & scamming your drs? Knock urself out. You’re going to do it anyway. Just remember that u are making it harder on a child & mother out there as well as people like me who seriously want to do good in this life & keep our ADHD out of the workplace and under control.

  • I am a young adult with narcolepsy and hypersomnia. If I don’t take my stimulants as soon as my alarms wakes me up, I will almost certainly fall back asleep within 1-3 minutes (it’s a physiological response). I have been on stimulants (adderall) for many years and I am getting my first RX for Adzenys on 12.16. I am hopefully that this can reduce the number of times I fall asleep before I can take my medicine. Swallowing pills while in bed is difficult. For people who do not live with these conditions, you can not understand the desperation/hopelessness/anxiety that comes with getting a CII every month. these medications are the difference between waking up and 7:30am and going to bed at 11pm, and waking up at 3pm and going to bed at 8pm.

    • How is the Adyenze doing for you and your Hypersomnia and Narcolepsy? I’m praying you’ll have success with this for m of the drug. My grandmother had Narcolepsy and I have IC and CFS, ME, which makes me exhausted but my son has severe ADHD and other disorders. He is again refusing to take any medication by mouth. He rarely eats ( that started prior to his ADHD diagnosis and stimulant intake) doesn’t even drink water unless I sit and make him. I worry about him. He is in Special Education and Gifted and Talented so we are lucky to have a close and tight knit community around him at his school. He’s now on an incentive/ reward program to take his meds at school and eat breakfast. I’m involved with another parent group and redesigning his schedules and reward charts. I just read your post earlier and wanted to check on you and wish you all the best. Laura

  • I was skeptical at 1st when my son was diagnosed Autistic with ADHD and ODD but at 4 years old he was having more serious problems then tantrums so he has been on medication for over a year and it’s been a fight he can’t swallow the capsule sprinkling it on his food only sets him off and makes him nervous about everything he eats and by the way most Autistic children already have sensory problems with eating so making them nervous about food doesn’t help my son lost 6lbs in a month because he was to scared I was hiding meds in his food. He tried the liquid that was a mess it tasted disgusting smell vile and was a thick creamy oblique substance that was measured out by a huge needle looking syringe that was supplied with the script so yea that didn’t quite work. And pills ha if you can find where he’s hiding it under his tongue after 5 tries he may chew it but then it changes the medicine so yea I was very pleased when his Dr offered the tablet version. Do I like the fact that my child takes a controlled substance of course not but until there’s a natural medicine that can calm him down and help him focus these tablets are his only option.

  • I agree with Dr. Ben Biermann. The people who would misuse such medications don’t really care what form it comes in. However, there are children out there who truly need this type of delivery system for this type of medication. That’s who we need to concentrate on.

  • And yet valid chronic pain patients are being criminalized and denied effective opioid maintenance, to the point that suicide rates have jumped since the CDC’s “recommendations” were taken as law. They’re killing us daily and nobody cares, all to push the growth of the profitable rehab industrial complex. My sister, an RN and Certified Case Manager for Blue Cross Blue Shield is gone, so how much more blood will the CDC have on its hands? Stop criminalizing legitimate pain patients!

    • I agree as long as there health is fine and its in low doses I agree with Dinah yep sure do ,its my right and I can speak about how I feel and about my own opinion

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