FDA Approves ADHD Treatment

SEPTEMBER 15, 2017
Kevin Kunzmann
The US Food and Drug Administration (FDA) has approved Amphetamine XR oral suspension drug (Adzenys ER) for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The treatment from Neos Therapeutics is based on the company's proprietary modified-release drug delivery technology platforms, and is an extended release amphetamine product. It is a once-daily, extended-release liquid medication, but does not require refrigeration or pharmacy reconstitution. 

Adzenys ER follows methylphenidate (Ritalin) extended-release oral tablet Cotempla XR-ODT as Neos' second ADHD treatment approved this year. Cotempla XR-ODT was approved by the FDA for ADHD pediatric patients in late June.

Adzenys ER also follows the trend of another Neos ADHD drug — Adzenys XR-ODTTM, the company's first FDA-approved amphetamine-based treatment for the condition. It was approved January 2016, and launched in May of that year.

Neos’ marketed array of amphetamine and methylphenidate treatment options for ADHD may have jumped in recent years, but the 2 treatment forms are long-standing in the condition’s pharmacological history.

Michael Manos, PhD, Head of the Center for Pediatric Behavioral Health at Cleveland Clinic Children’s Hospital, told MD Magazine that amphetamine for pediatric ADHD first came to fruition 80 years ago.



“Pharmacotherapy with ADHD has made a profound breakthrough, and it started way back in 1937 when George Still used amphetamine for a group of children in a hospital he founded,” Manos said. “In the hospital, it was for boys who did not themselves comport appropriately in school and oftentimes at home.”

Though amphetamine was first given to the children as a headache treatment, it aided them in staying focused in the classroom, Manos said. Patients only further aided when methylphenidate, in the form of Ritalin, came to the front of ADHD care.

“Both of these medicines have been around for quite awhile,” Manos said. “So there really are still 2 primary stimulants used. There are close to 29 — or even more now — different ways of delivering these 2 chemicals.”

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