The company touts its product, Cotempla XR-ODT, as the 1st methylphenidate tablet designed to release medication over time instead of all at once.
For years, children with ADHD have been treated with methylphenidate and amphetamines. But kids can sometimes have trouble swallowing orally-administered pills. Neos designed its product to be available in a tablet that dissolves on the tongue.
According to the company, Cotempla XR-ODT will be commercially available in the fall of this year.
Neos had to resubmit its application for approval from the FDA in December, after the regulatory watchdog asked the company to conduct another study comparing the drug used in clinical trials and the 1 that the company wanted to sell.
“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,” president & CEO Vipin Garg said in prepared remarks. “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.”