FDA Approves ADHD Medication

Officials with the FDA have approved an extended-release amphetamine (Adzenys ER, Neos Therapeutics) oral suspension for the treatment of attention-deficit hyperactivity disorder (ADHD), according to a company press release.

Once commercially available, Adzenys ER oral suspension will be the third Neos extended release product for the treatment of ADHD, joining Adzenys XR-ODT® (amphetamine) Extended-Release Orally Disintegrating Tablets and Cotempla XR-ODT™ (methylphenidate) Extended-Release Orally Disintegrating Tablets.

Adzenys ER, formerly referred to as NT-0201, is a once-daily, extended-release liquid medication that does not require refrigeration or reconstitution at the pharmacy level, according to the release.

“It is important for physicians to have a wide choice of medicines to help our patients with ADHD manage their symptoms,” Michael Feld, MD, a Northbrook, IL-based Child, Adolescent, and Adult Psychiatrist specializing in the treatment of ADHD said in a press release. “As a once-daily liquid formulation, Adzenys ER can play a role in meeting the individual needs of my patients.”

Adzenys ER is expected to become available in early 2018.

Reference

Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER™ (amphetamine) Extended-Release Oral Suspension for the Treatment of ADHD in Patients 6 Years and Older (news release). Dallas, TX. http://investors.neostx.com/phoenix.zhtml?c=254075&p=RssLanding&cat=news&id=2301045. Accessed September 15, 2017.