Neos Therapeutics Launches ADHD Drug Cotempla XR-ODT in the U.S.

Neos Therapeutics (NEOS) fell marginally in Monday’s afternoon trade after the pharmaceutical company said it has launched Cotempla XR-ODT in the United States.

Commercially available in select markets since September 2017, Cotempla XR-ODT is the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 to 17 years old.

The company said that it evaluated Cotempla XR-ODT in a laboratory classroom study in children with ADHD and the data showed a statistically significant improvement in ADHD symptoms compared to placebo averaged across the classroom day. Onset of effect was evident at one hour post-dose and symptom control lasted through 12 hours. In addition, there was a 61% improvement in ADHD symptoms when treated with Cotempla XR-ODT at one hour versus baseline.

There were no serious adverse events reported during the trial, and the adverse events profile appears similar to the established tolerability profile for other extended-release methylphenidate products.

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