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Neos Therapeutics, 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 the launch of Cotempla XR-ODT in select markets. The full nationwide market launch of Cotempla XR-ODT will occur in early October. The product was approved by the US Food and Drug Administration (FDA) on June 19, 2017 and is 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 pleased to be making this new once-daily methylphenidate product available now and to allow doctors to become familiar with Cotempla XR-ODT as they see patients during the back-to-school season,” said Vipin K. Garg, Ph.D., President and CEO of Neos Therapeutics. “This launch of our second product demonstrates our continued commitment to improving the lives of patients with ADHD. The positive feedback that we have received from physicians regarding their patients who are taking our first marketed product, Adzenys XR-ODT, amphetamine extended-release orally disintegrating tablets, leads us to believe that Cotempla XR-ODT will be an attractive treatment option for patients for whom methylphenidate is appropriate.”
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 averaged across the classroom day (placebo-subtracted difference of -11 [95% CI -13.9, -8.2]). Onset of effect was evident at one hour post dose and lasted through 12 hours. No serious adverse events were reported during the trial, and the adverse event profile appears similar to the established safety profile for other extended-release methylphenidate products. In addition, data from a bioequivalence study as well as a pharmacokinetic study in children with ADHD were also submitted.
Cotempla XR-ODT and Adzenys XR-ODT are federally controlled substances (CII). Central nervous system (CNS) stimulants (methylphenidate and amphetamine-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.
“The availability of Cotempla XR-ODT is good news for the children and adolescents diagnosed with ADHD, as it offers a wonderful new treatment option to help them manage their symptoms,” said James C. Anderson, MD, managing physician of Cornerstone Pediatrics at Premier in Greensboro, NC. “I personally have patients who are excited to try this extended-release methylphenidate product.”
Cotempla XR-ODT is a CNS stimulant prescription medicine used for the treatment of ADHD in children 6 to 17 years of age. Cotempla XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.
Neos therapeutics introduces cotempla xr-odt er tablets, treat adhd in patients 6 to 17 years old
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