Adzenys XR-ODT™ (extended-release, orally disintegrating tablet) is a new form of central nervous system (CNS) stimulant prescription medication for treating Attention Deficit Hyperactivity Disorder (ADHD) in children. The extended-release dissolvable tablets share their active ingredient, amphetamine, with well-known ADHD medications such as Adderall®. As a matter of fact, the drug has demonstrated bioequivalence to Adderall XR®, an extended-release mix of amphetamine salts and one of the most commonly prescribed ADHD medications in the United States.
Adzenys XR-ODT™ was approved by the United States Food and Drug Administration (FDA) through the 505(b)(2) regulatory pathway back in January, and was released last week. The FDA has not approved the drug for children under the age of six. The new tablets are being marketed as children’s chewables, and have a fruity flavor. One of the obvious benefits of Adzenys XR-ODT™ over Adderall XR® is due to the fact that many children — and some adults — have great and genuine difficulty swallowing pills.
— Stacey Wachtfogel (@swachtfogel) May 26, 2016
Adzenys XR-ODT™ has sparked worry among parents and psychiatrists, which is understandable, as many of us were told during our childhoods that medicine is not candy, and parents are often warned away from depicting medicine as candy in any way, shape, or form — even the famed Flintstones vitamins can cause controversy, depending on a parental or medical viewpoint. It’s worth pointing this out and thus recognizing the kneejerk reaction that this will cause before considering the pros and cons of this new ADHD medication.
Adzenys XR-ODT™, which comes in six dosage strengths ranging from 3.1 milligrams to 18.8 milligrams, has also resulted in consternation due to the seemingly flippant marketing tone that has surrounded this ADHD medication during the past week. The pharmaceutical company behind this drug is called Neos Therapeutics and is based in Dallas, Texas. The CEO of Neos Therapeutics, Vipin Garg, seemed to make a stunningly inappropriate and tone-deaf pun using the word “speed” — street lingo for illegally sold and abused amphetamine and methamphetamine — when commenting to the press about the release of Adzenys XR-ODT™. He stated that Neos Therapeutics has been stepping up their marketing efforts in order to get “ahead of back-to-school season,” and added, “We’re launching now at full speed,” according to medical blog STAT. Could that really have been unintentional?
Vipin Garg also spoke about the new ADHD medication as if it is part of a back-to-school sale at a department store.
“We look forward to offering patients, their parents and caregivers with [sic] this new treatment option ahead of the back-to-school season this summer, and expanding our focus into newly diagnosed pediatric patients and adolescent and adult patients. Keeping patient cost at a reasonable level to ensure access is an important consideration. We’re offering a coupon in which patients can receive a 30-day free trial of Adzenys XR-ODT, as well as a program of up to one year in which patients pay as little as $25 per prescription. […] For Cotempla XR-ODT, we are on-track to complete the bridging study in the third quarter of this year to demonstrate bioequivalence between clinical trial material and the to-be-marketed drug product, including an assessment of food effect. […] If approved, we believe we will have the only two extended-release orally disintegrating tablets for the two most commonly prescribed drugs for ADHD on the market by the 2017 back-to-school season.”
— Mary Wieder (@MaryW_CROSNT) February 16, 2016
STAT spoke to two doctors who expressed their concerns about Adzenys XR-ODT™ and its introduction to the American market. Stimulants that are currently on the market are known for their abuse by teenagers and college students, some of whom use them as party drugs and some of whom use them for performance enhancement and to reduce the need for sleep while studying. With this in mind, Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist in Napa, California, told STAT that he fears a flavored, chewable ADHD medication will be “a recipe for people to request it and then sell it.”
“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.”
Dr. Alexander Papp, an adult psychiatrist affiliated with University of California, San Diego, also expressed disapproval. “An orally disintegrating amphetamine for kids by the morally disintegrating FDA,” he told STAT. “What’s next? Gummy bears?”
The medicine-as-candy concern dovetails with the concern among Americans about the overmedication of children who are diagnosed with ADHD, a concern that dates back to the 1990s when the popular prescription was Ritalin®. STAT biotech reporter Meghana Keshavan writes that 75 percent of children with an ADHD diagnosis are on medication.
“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.”
Dr. Greg Mattingly, a child psychiatrist who teaches pharmacology at the Washington University School of Medicine, says that he approves of the prescription of Adzenys XR-ODT™ for children who have trouble swallowing pills, and has already had success with a 9-year-old male patient of his with this exact problem.
Dr. Ben Biermann, an assistant professor of psychiatry at University of Michigan’s C.S. Mott Children’s Hospital, reminded STAT readers that Adzenys XR-ODT™ is just a new form of an existing ADHD medication, therefore it should not be a cause for overreaction.
“There’s nothing revolutionary about this drug. It’s simply another delivery mechanism for a medication that already exists and has widespread use.”
Adzenys XR-ODT™ is the first and only extended-release orally disintegrating tablet (XR-ODT) for the treatment of ADHD. It is available in the United States by prescription only. STAT reports that “analysts are generally bullish about [Neos Therapeutics’s] prospects.”
What do you think about Adzenys XR-ODT™? Is it appropriate for children? Will it increase risk of abuse?