FDA Approves First Orally Dissolvable Methylphenidate Tablets for ADHD


The FDA has approved Cotempla XR-ODT (methylphenidate) extended-release orally disintegrating tablets from Neos Therapeutics, the company announced in a press release.

Officials with the FDA have approved methylphenidate (Cotempla XR-ODT, Neos Therapeutics) extended-release orally disintegrating tablets. The tablets are indicated to treat attention-deficit/hyperactivity disorder (ADHD) in patients aged 6-17 years old.

The approval is based on data from a phase 3 clinical trial that supports the safety and efficacy of Cotempla XR-ODT. In the trial, treatment demonstrated a statistically significant improvement in ADHD symptoms compared to a placebo in children in a laboratory classroom. The drug’s effectiveness was indicated at 1 hour after the dose was received and lasted for 12 hours. No serious adverse events were reported.

Due to its high potential for abuse and dependence, Cotempla XR-ODT and Adzenys ZR-ODT are schedule II controlled substances. Health care providers are urged to assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence.

“Cotempla XR-ODT offers a new methylphenidate option in ADHD management because it dissolves in the mouth with no need for chewing or drinking water,” Ann Childress, MD, President of the Center for Psychiatry and Behavioral Medicine, said in a press release. “It has a clinical profile consistent with commonly prescribed methylphenidate ADHD treatments, which are generally available as capsules that must be swallowed whole.”

Cotempla XR-ODT will be available in a portable, child-resistant blister pack in the fall of 2017.


Neos Therapeutics announces FDA approval of Cotempla XR-ODT™ (methylphenidate) extended-release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old [news release]. Texas. Neos’ website. http://investors.neostx.com/phoenix.zhtml?c=254075&p=RssLanding&cat=news&id=2281776. Accessed June 20, 2017.

Related Videos
BillionPhotos.com - stock.adobe.com
Whole psilocybin mushroom in a clear medication capsule | Image credit: Zim - stock.adobe.com
Patient suffering from atopic dermatitis -- Image credit: Nikkikii | stock.adobe.com
Image credit: Fabio Balbi | stock.adobe.com
Image credit: Melita - stock.adobe.com
Atopic dermatitis on a patient's hand -- Image credit: Ольга Тернавская | stock.adobe.com
cropped view of man performing chest compression on dummy during cpr training class - Image credit: LIGHTFIELD STUDIOS | stock.adobe.com
Medicine law concept. Judges gavel with pills | Image Credit: Iren Moroz - stock.adobe.com
Image credit: New Africa | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.