A New Chewable "Gummy Bear" ADHD Drug Approved by #FDA | Pharma Industry Regulation | Scoop.it

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.

 

“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,” said Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist in Napa, Calif.

 

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 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.

 

About 75 percent of children diagnosed with ADHD are on medication — a statistic that concerns many psychiatrists.

 

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?”

 

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?”