Neos Therapeutics, a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery technologies, announced the US launch of Cotempla XR-ODT. Commercially available in select markets since September 2017, Cotempla XR-ODT 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 evaluated Cotempla XR-ODT in a laboratory classroom study in children with ADHD and the data showed a statistically significant improvement in ADHD symptoms compared to placebo averaged across the classroom day,” said Andrew J. Cutler, MD, executive vice president and chief medical officer of Meridien Research in Tampa, Florida and a principal investigator in the Cotempla XR-ODT clinical studyi. “Onset of effect was evident at one hour post-dose and symptom control lasted through 12 hours. In addition, there was a 61% improvement in ADHD symptoms when treated with Cotempla XR-ODT at one hour versus baseline.”
No serious adverse events were reported during the trial, and the adverse events profile appears similar to the established tolerability profile for other extended-release methylphenidate products (most common adverse events for Cotempla XR-ODT are decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure). Cotempla XR-ODT was approved by the US Food and Drug Administration (FDA) on June 19, 2017.
Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. 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.
“We are very encouraged by the feedback we have been getting from physicians about Cotempla XR-ODT,” said Vipin K. Garg, Ph.D., president and chief excuetive officer of Neos Therapeutics. “With the availability of Cotempla XR-ODT, Adzenys XR-ODT (amphetamine) Extended-Release Orally Disintegrating Tablets, and the recent approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension, Neos is providing physicians with additional options to help address the individual needs of their patients with ADHD.”