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FDA approves disintegrating Cotempla tablet for ADHD
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Neos Therapeutics Inc. recently announced the FDA approved Cotempla XR-ODT, an extended-release orally disintegrating tablet, for the treatment of ADHD in children aged 6 to 17 years.
“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,” Ann Childress, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, said in a press release. “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.”
The approval was based on findings from a phase 3 clinical trial conducted among children in a laboratory classroom setting.
Study participants who received Cotempla XR-ODT exhibited statistically significant improvement in ADHD symptom control throughout the classroom day, with a placebo-subtracted difference of –11 (95% CI, –13.9 to –8.2), comparted with placebo.
Treatment effect onset began 1 hour postdose and was sustained for 12 hours.
There were no serious adverse events reported.
The adverse event profile was comparable to those of other extended-release methylphenidate safety profiles, according to researchers.
Cotempla XR-ODT will be commercially available in portable, child-resistant blister packs in fall 2017.
“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,” Vipin K. Garg, PhD, president and CEO of Neos Therapeutics, said in the press release. “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.”