FDA Clears Liquid Extended-Release Amphetamine for ADHD

Megan Brooks

September 19, 2017

The US Food and Drug Administration (FDA) has approved amphetamine extended-release oral suspension (Adzenys ER, Neos Therapeutics Inc) for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and older, the company has announced.

The FDA has already approved Neos Therapeutics' amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT) and the company's methylphenidate extended-release orally disintegrating tablets (Cotempla XR-ODT) for ADHD in children aged 6 years and older.

The FDA approval of Adzenys ER "unlocks yet another treatment option for ADHD patients and their caregivers who are seeking a liquid extended-release amphetamine product and provides a different dosage form of our already approved Adzenys XR-ODT, " Vipin K. Garg, PhD, president and CEO of Neos Therapeutics, said in a news release.

Adzenys ER is given once daily and does not need to be refrigerated or reconstituted at the pharmacy level, the company says.

Because Adzenys ER uses the same proprietary modified-release drug delivery technology as Adzenys XR-ODT, healthcare providers have the option of transitioning appropriate patients from liquid to ODT formulations, the company notes. Both Adzenys ER and Adzenys XR-ODT are bioequivalent to mixed amphetamine salts extended-release capsules (Adderall XR, Shire).

"It is important for physicians to have a wide choice of medicines to help our patients with ADHD manage their symptoms. As a once-daily liquid formulation, Adzenys ER can play a role in meeting the individual needs of my patients," Michael Feld, MD, Illinois-based child, adolescent, and adult psychiatrist specializing in the treatment of ADHD, said in the release.

Adzenys ER will be commercially available in early 2018.

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