FDA Clears First ADHD Bedtime Medication

Megan Brooks

August 10, 2018

The US Food and Drug Administration (FDA) has approved Jornay PM (Ironshore Pharmaceuticals), a novel formulation of methylphenidate that is taken in the evening instead of first thing in the morning to provide early-morning control of symptoms of attention-deficit/hyperactivity disorder (ADHD).

Jornay PM is for children aged 6 years and older. It should be taken at 8:00 PM, although timing of administration may be adjusted to between 6:30 PM and 9:30 PM to optimize the tolerability and the efficacy the next morning and throughout the day, the company said.

"Many parents of children with ADHD note that the early morning routine is often one of the most chaotic times of the day," Randy Sallee, MD, chief medical officer at Ironshore, said in a news release.

"The idea of dosing the medication the night before was our 'moonshot' solution to meeting this need. The approval of Jornay PM is a welcome treatment option for healthcare providers, patients, and their caregivers that may affect the way physicians think about ADHD treatment going forward," said Sallee.

Jornay PM is the first drug to utilize Ironshore's novel, proprietary drug delivery platform, Delexis. It contains two functional film coatings that act synergistically to achieve a unique pharmacokinetic profile. The first layer delays the initial release of drug for up to 10 hours, and the second layer helps to control the rate of release of the active pharmaceutical ingredient throughout the day.

In two phase 3 randomized, double-blind, placebo-controlled studies involving a total of 278 children aged 6 to 12 years who had been diagnosed with ADHD, Jornay PM improved the severity of ADHD symptoms in the early morning and throughout the day, the company said.

Accumulated data from other methylphenidate products indicate that the most common adverse reactions for pediatric patients and adults are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.

Additional adverse reactions (occurring in >5% of patients at twice the rate of reactions to placebo) in pediatric patients aged 6 to 12 years treated with Jornay PM include headache, psychomotor hyperactivity, and mood swings.

Full prescribing information is available online.

Jornay PM should be available in the first half of 2019.

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