Neos Therapeutics announced that the Food and Drug Administration (FDA) has approved Cotempla XR-ODT (methylphenidate extended-release) orally-disintegrating tablets for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6–17 years.
Cotempla XR-ODT is the first methylphenidate extended-release orally-disintegrating tablet approved. The FDA’s decision was based on Phase 3 study data of children in a laboratory classroom setting. Patients using Cotempla XR-ODT showed a significant improvement in ADHD symptom control vs. placebo across the classroom day (placebo-subtracted difference –11, 95% CI: –13.9, –8.2). Efficacy was evident at one hour post-dose and lasted through 12 hours.
The study reported no serious adverse events; the safety profile was comparable with the known profile for other extended-release methylphenidate products.
Cotempla XR-ODT, a Schedule II controlled substance, will be available as child-resistant blister packs containing thirty 8.6mg, 17.3mg or 25.9mg strength tablets. It is anticipated to launch in the Fall of 2017.
For more information call (888) 319-1789 or visit Neostx.com.