Neos Therapeutics announced the availability of Cotempla XR-ODT (methylphenidate extended-release) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6–17 years. The drug, approved in June 2017, marks the first methylphenidate extended-release orally-disintegrating tablet (ODT) for the treatment of ADHD in this population.

Cotempla XR-ODT contains methylphenidate, a central nervous system (CNS) stimulant. Its initial approval was based on Phase 3 clinical data that evaluated children in a laboratory classroom setting. Children who received Cotempla XR-ODT exhibited a statistically significant improvement in ADHD symptom control vs. those who received placebo averaged across the classroom day. There were no serious adverse events observed during the study. 

Related Articles

Cotempla XR-ODT is a Schedule II controlled substance and is supplied as 8.6mg, 17.3mg, and 25.9mg strength ODT in cartons containing 5 blister cards of 6 tablets each. Currently, Cotempla XR-ODT is available in certain markets and will be available nationwide in early October.

For more information call (888) 319-1789  or visit