Neos Therapeutics announced the nationwide availability of Cotempla XR-ODT (methylphenidate extended-release) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6–17 years of age. 

“We 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,” said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer of Meridien Research in Tampa, Florida and a principal investigator in the Cotempla XR-ODT clinical study. “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.”

Cotempla XR-ODT is a Schedule II controlled substance and is supplied as 8.6mg, 17.3mg, and 25.9mg strength orally-disintegrating tablets in cartons containing 5 blister cards of 6 tablets each.

With regard to administration, healthcare professionals should instruct patients and their caregivers on the following:

  • The tablet should remain in the blister pack until the patient is ready to take it; once opened it should not be stored for future use
  • Use dry hands when opening the blister pack; do not push the tablet through the blister pack
  • As soon as the blister is open, the tablet should be removed and placed on the patient’s tongue
  • The tablet will disintegrate on the patient’s tongue without chewing or crushing; no liquid is needed 

In addition, patients should be advised to avoid alcohol while taking Cotempla XR-ODT as consumption may result in a more rapid release of the dose of methylphenidate. 

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