BY HELEN DWORK/ADDITUDE
August 10, 2018
The FDA approved JORNAY PM, a new formulation of methylphenidate, for the treatment of attention deficit disorder (ADHD or ADD) in patients 6 years and older. Ironshore Pharmaceuticals plans to make the drug available commercially in the first half of 2019.
JORNAY PM (previously known as HLD200) is designed to be taken before going to sleep, instead immediately upon waking, to provide early-morning symptom control. It uses DELEXIS, a proprietary drug delivery technology, to provide long-acting coverage with two functional film coatings:
An outer layer that delays the medication’s release overnight (for up to 10 hours)
An inner layer that controls the rate of release throughout the day
“Many parents of children with ADHD note that the early morning routine is often one of the most chaotic times of the day. The idea of dosing the medication the night before was our moon-shot solution to meeting this need,” says Dr. Randy Sallee, Chief Medical Officer at Ironshore. “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.”
The FDA granted approval after two separate Phase III studies, with 278 total participants, demonstrated statistically significant improvement of ADHD symptoms for children ages 6-12 taking JORNAY PM when compared to a placebo. The studies measured symptom control in two settings: a classroom and during the early morning hours before school.
In the first study, all participants received JORNAY PM for six weeks. In the seventh week, participants were randomly selected to continue taking JORNAY PM or switch to a placebo. Teachers rated classroom symptoms using the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) Scale. Parents rated early morning symptoms on the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale.
In the second study, randomized participants received JORNAY PM or placebo for three weeks. Symptom improvement was measured by the ADHD Rating Scale (ADHD-RS-IV) Total Score, and the Before School Functioning Questionnaire (BSFQ).
During the open-label JORNAY PM treatment phase of testing, the most common adverse reaction reported was insomnia (41%). Side effects were similar to other methylphenidate products, and in addition, Ironshore reports adverse reactions of headache, psychomotor hyperactivity, and mood swings.
JORNAY PM has been designated a Schedule II controlled substance, indicating that it has a high potential for abuse.