At a time when the use and overuse of amphetamine and methylphenidate-based medications among “hyperactive” children is being called into question, a pharmaceutical company known as Neos Therapeutics has managed to win FDA approval for not one, but two new chewable, fruit-flavored ADHD/ADD drugs.
As one might imagine, these new candy-flavored prescription drugs are aimed directly at the 6 to 17-year-old demographic – and mental health professionals are already concerned that they will fuel an already alarming trend toward overmedicating children. They may also exacerbate the already serious problem of amphetamine addiction among youth and young adults.
One of these new ADHD meds is known as Adzenys, a form of levoamphetamine. This ingredient is also found in Benzadrine (now known as Evekeo) and Adderall. Adzenys XR-ODT won FDA approval in January for children age six and older. Available in six different dosages, Texas-based Neos has already revved up its marketing and promotions so as to get “ahead of back-to-school season,” according to company CEO Vipin Garg.
With a sales force of 125 representatives deployed across the country, Garg says the company is having “no problem” seeing physicians and winning them over on the new product. It is what some concerned organizations aptly describe as a “shameless marketing campaign.” It’s also drawn fire from those in the health care community who are rightfully concerned about the growing problem of amphetamine addiction among children and teens.
That hasn’t stopped Neos Therapeutics from moving ahead with yet another chewable med. Known as Cotempla, this new prescription drug is the first methylphenidate medication (of which Ritalin is one example) of its kind – an extended-release pill that dissolves in the mouth. Speaking to Fierce Pharma, Garg points out that “doctors like to start younger patients on methylphenidates transition them over to amphetamines as they get older…by having both of these molecules, we’ll be able to address, basically, patients right from six years of age all the way into their adulthood.”
Garg is also optimistic over Cotempla’s sales projections. Currently, there are no plans to expand the company’s sales force – they’re simply going to build on what they’ve already done with Adzenys. “That’s the beauty of it,” he says. “We’re going to be able to leverage the commercial infrastructure we have put in place.”
Not everyone in the medical profession is sold, however. While these new fruit-flavored meds may offer convenience and make it easier for parents to keep their children medicated, a child psychiatrist from Napa, California says it will make it easier to “divert” these medications. Dr. Mukund Gnanadesikan told STAT that it is “a recipe for people to request it and then sell it.” He added, “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.”
Of course, Neos Therapeutics is simply doing what corporations do – which is to maximize profits by any means possible, costs to human health and life be damned. Ultimately, the responsibility falls squarely on the shoulders of the FDA – which has been sorely falling down on the job when it comes to protecting consumers these days. In the words of adult psychiatrist Dr. Alexander Papp, it was the approval of “an orally disintegrating amphetamine for kids by the morally disintegrating FDA….what’s next? Gummy bears?”