Neos, facing criticism, wins approval for another easy-to-take pediatric ADHD medication

Neos already markets Adzenys, an orally disintegrating amphetamine for ADHD.

There’s a new FDA-approved ADHD medication on the scene, and it’s one maker Neos Therapeutics thinks will put it in prime market position. But it also may compound the backlash it’s already facing over its easy-to-take, potentially addictive pediatric meds.

Monday, U.S. regulators green-lighted the Texas drugmaker’s Cotempla, an extended-release tablet that disintegrates in the mouth, for patients ages 6 to 17.

It’s the first methylphenidate med that can boast both those features, and it joins Adzenysa long-acting amphetamine in the same formin the company’s portfolio. Now, physicians will be able to choose a an extended-release, orally disintegrating tablet (XR-ODT) med from Neos no matter which of the two categories they want to go withand those categories cover 90% or more of all ADHD prescriptions, Neos CEO Vipin Garg told FierecPharma in a recent interview.

What’s more, “typically doctors like to start younger patients on methylphenidates transition them over to amphetamines as they get older,” Garg said. So, “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.”

To market its meds across that spectrum, Neos won’t have to bolster its representative army. Right now, the company isn’t planning to add reps or move them around in order to reach its target doctor population.

“That’s the beauty of it,” Garg said. “We’re going to be able to leverage the commercial infrastructure we have put in place.”

Neos, though, is already taking heat from critics who worry Adzenys’ appealing flavor and convenient dosing form are helping fuel an overprescription problemand could lead to drug abuse. And the addition of Cotempla to the lineup could spark more ire.

It’s “a recipe for people to request it and then sell it,” said Mukund Gnanadesikan, a California-based child and adolescent psychiatrist, told STAT News last month, adding, “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.”

Garg, though, sees things differently. Adzenys isn’t the only flavored ADHD drug out there, he saidit was the sixth to win the FDA’s favorand “this whole idea of over-diagnosis and prescription ... really has nothing to do with Adzenys,” he contended.

“All along, some people have had that concern, and clearly that’s something we really don’t promote ... We’re not telling doctors to prescribe for ADHD. We’re simply telling them, ‘if you have a patient that’s already diagnosed with ADHD, Adzenys is another option that you can consider in their treatment,’” he said.

Analysts, meanwhile, predicted Cotempla could capture considerable sales thanks to the size of the ADHD market. Methylphenidate prescriptions generated approximately $3.4 billion 2016 U.S. sales, with Johnson & Johnson’s Concertaan ER tabletand its generics racking up $1.8 billion of that haul, Wells Fargo’s David Maris wrote in a note to clients.

“We believe this product could grow to more than $135 million in sales by 2022,” he said, noting that “if one assumes that Cotempla XR-ODT could have sales of 5% of the market, or 10% of Concerta sales, then Cotempla XR-ODT would have sales of approximately $170 million to $180 million.”

RBC Capital Markets’ Randall Stanicky thinks Cotempla’s ceiling is even higher. He’s estimating peak penetration of 4.8%, or sales of $221 million.