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.