FDA Approves New ADHD Drug for Children


Methylphenidate (Cotempla XR-ODT) extended-release orally disintegrating tablets approved to treat children with attention-deficit/hyperactivity disorder.

Neos Therapeutics recently announced the approval of methylphenidate (Cotempla XR-ODT) extended-release orally disintegrating tablets for children aged 6 to 17 years with attention-deficit/hyperactivity disorder (ADHD).

The approval makes the drug the first and only methylphenidate extended-release orally disintegrating tablet indicated for this population, according to a press release.

ADHD is estimated to affect 5% of children and 2.5% of adults in the United States. Symptoms of inattentiveness, hyperactivity, and impulsiveness can affect performance at school and work, and can affect day-to-day life, making medication necessary.

“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, PhD, 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 methylphenidate was supported by positive findings from a phase 3 clinical trial that included children in a laboratory classroom setting.

The investigators discovered that treatment with methylphenidate significantly improved ADHD symptom control throughout the classroom day compared with placebo, according to the study. Symptom control was observed 1 hour after the dose and was sustained for 12 hours.

There were no serious adverse events reported, and the drug’s safety profile was consistent with the profile of other methylphenidate products, according to the release.

Common side effects include decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and hypertension.

Since the drug is a central nervous system stimulant, it is a schedule 2 controlled substance due to potential for misuse and dependence. Neost advises that physicians assess the risk of abuse prior to prescribing and continually monitor patients for signs of misuse and dependence.

Methylphenidate extended-release orally disintegrating tablets will be available in a portable, child-resistant blister pack this year, according to the release.

“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, 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.”

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