Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Approves ADHD Treatment for Patients 6-17 Years Old

By Globe Newswire | June 20, 2017

Neos Therapeutics announces FDA approval of Cotempla XR-ODT™ (methylphenidate) extended-release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 Years old.

Neos Therapeutics, Inc., 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.

(Source: Globe Newswire)

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!

Related Articles Read More >

FDA logo
FDA prevented 317 drug shortages in 2021
Pfizer-BioNTech vaccine vial
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
FDA logo
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
FDA logo
FDA sends warning letters to CBD and delta-8 THC product vendors

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards