Neos Therapeutics, a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technologies, announced that the U.S. Food and Drug Administration (FDA) approved Cotempla XR-ODT, 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.
“We are excited about the FDA approval of Cotempla XR-ODT, which offers patients and caregivers a new treatment option to manage the symptoms commonly associated with ADHD,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form. We look forward to having Cotempla XR-ODT join our Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets on the market this fall.”
The approval of Cotempla XR-ODT was supported by a Phase 3 clinical trial in children in a laboratory classroom setting. Treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day (placebo-subtracted difference of -11 [95% CI -13.9, -8.2]). Onset of effect was evident at one hour postdose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.i In addition, data from bioequivalence and pharmacokinetic studies in children with ADHD was also submitted.ii
Cotempla XR-ODT and Adzenys XR-ODT are Schedule II controlled substances. CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Physicians should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence.
“Cotempla XR-ODT offers a new methylphenidate option in ADHD management because it dissolves in the mouth with no need for chewing or drinking water. It has a clinical profile consistent with commonly prescribed methylphenidate ADHD treatments, which are generally available as capsules that must be swallowed whole,” said Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, NV. “Cotempla XR-ODT will offer physicians and their patients a differentiated treatment option that combines the convenience of once-daily dosing with an orally disintegrating methylphenidate dosage form.”
Cotempla XR-ODT will be commercially available in a portable, child-resistant blister pack in the fall of 2017.
Filed Under: Drug Discovery