Cotempla XR-ODT approved for children, adolescents with ADHD

 

The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.

The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose 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.

“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, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, 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.”

Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.

Find the full press release on Neos Therapeutics website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.

The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose 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.

“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, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, 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.”

Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.

Find the full press release on Neos Therapeutics website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration has approved the first methylphenidate extended-release orally disintegrating tablet for treating ADHD in patients aged 6-17 years old, Neos Therapeutics announced June 19.

The company said the approval came after a phase III trial showed that treatment in a laboratory classroom with the drug, called Cotempla XR-ODT, showed a significant improvement in attention-deficit/hyperactivity disorder symptom control when compared with a placebo across the classroom day (placebo-subtracted difference of –11). The onset of effect was shown at 1 hour post-dose 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.

“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, MD, president of the Center for Psychiatry and Behavioral Medicine, Las Vegas, 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.”

Cotempla XR-ODT will be available commercially in a portable, child-resistant blister pack in the fall of 2017.

Find the full press release on Neos Therapeutics website.

llaubach@frontlinemedcom.com