A sweet, dissolvable stimulant for kids with Attention-Deficit Hyperactivity Disorder (ADHD) hit the market this month to a salty reception. “Tasty And Easy To Take, A New ADHD Drug Alarms Some Psychiatrists,” read medical site STAT’s headline; “Scary New Adderall-Type Drug for Children Looks & Tastes Just Like Candy” read another on Jezebel.
Concerned doctors called Adzenys, an orange-flavored orally disintegrating pill a “recipe for people to request it and then sell it.” Others worried that a medicine targeting kids would exacerbate the “over-medicating” of that demographic. Their overarching conclusion: the risks associated with this drug outweigh the benefits.
But what if they’re wrong?
Admittedly, the concept of kids smiling with a candy-flavored amphetamine on their tongue—which is, fittingly, the marketing picture—is disarming. But despite the unease that accompanied Adzenys launch, Harvard neuropsychiatrist Dr. Theresa Cerulli, who specializes in ADHD, argues the drug is actually safer and could positively benefit millions of families nationwide.
After years of working with families of children with ADHD, she says getting them to take medicine is a major hurdle—one that a dissolvable pill just might fix. If it does, it could have wide-ranging effects. According to the Centers for Disease Control and Prevention, 11 percent of American children in the U.S. aged 4-17 had been diagnosed with ADHD by 2011.
Those struggling not only face difficulty with school, but are 10 percent more likely to experience major injuries than their peers. For the estimated 6 million families trying to manage kids with the disorder, an easier way to manage the symptoms of the disease could prove life-changing.
“A huge barrier to treatment is that they just don’t want to take pills,” Cerulli told The Daily Beast. “There’s a misconception that kids want to be on medicine. Most of these kids don’t.” One part of the problem, she said, has to do with stigma. Kids feel anxious about taking a pill because it makes them “weird” or different from peers.
But the bigger part, according to Cerulli, is a simple fact: the majority of kids hate swallowing pills. Studied since the 1980s, it’s a concept that was recently revived in a 2015 survey from Pediatrics, in which 50 percent of parents said they had kids who couldn’t swallow a pill. While the study suggested potential therapeutic interventions, she said forcing kids into swallowing something they don’t want to can exacerbate the problem.
Cerulli’s own daughter suffers from ADHD. Trying to convince her to swallow a pill every morning is “a huge hurdle” that threatens to throw off her routine—an important precursor to a good day. “You’re trying to get everything organized, your schedule, get your kids out the door, and it’s chaos,” she said. “To have anything that makes it easier, it makes the compliance and the family’s ability to handle it go way up.”
Chemically similar to extended-release Adderall, the drug was approved the Food and Drug Administration in January, four years after its initial petition. In the FDA’s clinical review, researchers deemed it so similar to Adderall XR that it considered the safety and efficacy studies of that drug “adequate to support the clinical doses of amphetamine in this product.”
Extended time release Adderall, or Adderall XR, is widely recognized as first-line treatment for both adults and children suffering from ADHD. Usually taken in a capsule, it contains two different chemicals which, together, prolong the release of the drug. Multiple studies have shown it to be effective at treating hyperactivity and impulse control in patients with ADHD—two hallmark symptoms of the disorder.
Scientists have proven Adderall XR safe enough for children. In a 2006 study, researchers from Harvard University tested the drug found it to cause “significant improvements” in adolescents with ADHD, leading them to deem it an “effective and well tolerated” solution for kids with the disorder. Adzenys, like its sister drug, seems well tolerated too. In an analysis listed in the clinical review, test subjects reported few adverse effects—mostly mild.
Neos Therapeutics, the Texas-based company behind it has also defended the product’s validity, insisting that it fills an “unmet need” in the market. “[Our goal] is to provide an alternative for patients and families that have struggled to find the right treatment for this serious neurobehavioral disorder,” a spokesperson from the company told The Daily Beast. “Patients in other disease categories have a variety of options at their disposal and patients with ADHD and their physicians should have the same treatment options available to them.”
The company also points out that adding flavor to bitter and unpleasant taste in medicines is a common practice in the medical world, a tactic that can “increase patient likelihood to stay on treatment.”
As for the black market, the orange-flavored pill may be less desirable than it seems. Since it's extended release, it provides a steady dose of the medicine all day, not an immediate high—a fact that makes extended release Adderall “far less likely” to be abused than the regular version. “Dissolving it isn't activating it,” says Cerulli of people who may want to abuse the drug. “With stimulant medications the highest abuse potential comes from short-acting medications. I think people are thinking of [Adzenys] as an even faster acting one and it’s the opposite.”
Not everyone agrees with the glowing assessment Cerulli has made. Nicolas Rasmussen, a historian and author of the book On Speed: The Many Lives of Amphetamine, worries that turning a “neurotoxic and addictive drug into candy” is dangerous because kids may like the taste enough to help themselves for more. It’s an important point, but one that seems parents—by hiding the medicine from their kids reach—could fairly easily circumvent.
Cerulli, who has experienced children with ADHD both as a parent and doctor, contends that Adzenys may open a new door for better treatment. “This can be more collaborative, so it doesn’t feel so invasive to the child. To have something that isn’t as much of a barrier, where the child doesn’t feel like they’re taking a pill, it’s incredibly useful,” she said. “I think unless families have lived it, they can’t understand.”