Long-acting version of Shire’s Adderall XR and Neos Therapeutics’ Cotempla XR-ODT orally disintegrating tablets provide new options.

Attention deficit hyperactivity disorder (ADHD) can affect the development of children. Recent data suggests that slightly more than 10% of American children suffer from ADHD, and more than 50% of them continue to deal with the disorder as adults. The US FDA recently approved two treatments for ADHD, both are long-acting products that reduce the frequency at which medication must be taken.

Shire received approval for Mydayis (SHP465), a long-acting (16 hours) version of its successful drug Adderall XR (12 hours) for the treatment of ADHD in adolescents and adults. While both are based on the stimulant amphetamine, which elevates levels of the neurotransmitter dopamine, the new product does extend the delivery of the active ingredient. It is designed to help college students and adults by reducing the need to take multiple doses during the day.

Shire plans to launch Mydayis in the third quarter of 2017 and expects to achieve sales of $500 million annually by 2020, despite analyst predictions of $294 million as compiled by Thomson Reuters. In 2016, Adderall XC and Shire’s other ADHD drug Vyvanse achieved sales of nearly $2.4 billion.

Neos Therapeutics was granted FDA approval for its methylphenidate extended-release orally disintegrating tablet Cotempla XR-ODT for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old.

The Texas-based company focuses on the development, manufacture and commercialization of innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technologies. With the approval of Cotempla XR-ODT, Neos will now be able to offer both branded extended-release methylphenidate and amphetamine (Adzenys XR-ODT^®) products in orally disintegrating tablet dosage forms. The company expects to have Cotempla XR-ODT tablets on the market in a portable, child-resistant blister pack in the fall of 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,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics.

Added Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, NV: “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. 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.”