FDA Approves ADHD Treatment With Nighttime Dosing
The US Food and Drug Administration has approved the first stimulant medication to be taken in the evening for the treatment of attention-deficit/hyperactivity disorder (ADHD), Ironshore Pharmaceuticals announced.
Jornay PM was approved for the treatment of ADHD in patients aged 6 and older. It has demonstrated improvement in the severity of ADHD symptoms in the morning after dosing and throughout the day.
The drug, formerly known as HLD200, is a novel, extended-release formulation of methylphenidate. It is expected to be on the market in the first half of 2019.
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“Many parents of children with ADHD note that the early morning routine is often one of the most chaotic times of the day,” said Randy Sallee, MD, PhD, chief medical officer at Ironshore.
Jornay PM should be taken at 8 pm, but dosing can be taken any time between 6:30 pm and 9:30 pm to optimize tolerability and efficacy, according to a statement from Ironshore.
The FDA approval comes after two phase 3 multicenter, randomized, double-blind and placebo-controlled studies, which involved 278 children aged 6 to 12 with a diagnosis of ADHD. In addition to traditional ADHD scales, the trials assessed the drug’s efficacy in the early morning with the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ).
Jornay PM is the first drug to use Delexis, Ironshore’s novel and proprietary drug delivery platform. The technology contains two functional film coatings, one that delays the initial release of drug for up to 10 hours and a second layer to help control the rate of release of the active pharmaceutical ingredient throughout the day.
In addition to adverse events commonly associated with methylphenidate products, adverse reactions in children taking Jornay PM were headache, psychomotor hyperactivity, and mood swings.
As with other stimulants, the label of Jornay PM will carry a black box warning advising of a high potential for abuse and dependence. The box urges prescribers to assess the risk of abuse before prescribing the drug and monitor for signs of abuse and dependence while it is used.
Ironshore Pharmaceuticals announces FDA approval of Jornay PM (methylphenidate) extended-release capsules CII for the treatment of ADHD [press release]. George Town, Cayman Islands: Ironshore Pharmaceuticals; August 9, 2018.