Full nationwide market launch of Cotempla XR-ODT will occur in early October
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.
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.
Source: Cotempla XR-ODT Available for Pediatric ADHD
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