Ironshore announced that the Food and Drug Administration (FDA) has approved Jornay PM (methylphenidate) extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 years.
Jornay PM utilizes the proprietary Delexis drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day. The product is intended for dosing in the evening; timing of the dose may be adjusted between 6:30–9:30 PM to optimize efficacy and tolerability.
Jornay PM was evaluated in two Phase 3, multicenter, randomized, double-blind, placebo-controlled studies (N=278) in pediatric patients aged 6–12 years with ADHD. The efficacy of Jornay PM in the early morning period was examined using the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ). Traditional scales used to assess efficacy in ADHD trials (SKAMP and ADHD-RS-IV) were also used.
In Study 1, improvement in ADHD manifestations in a classroom setting was observed based on the average of all post-dosed SKAMP combined scores during a 12-hour period (primary endpoint). In addition, an improvement in ADHD manifestations in the early morning was demonstrated by the PREMB-R AM scale (secondary endpoint). In Study 2, ADHD-RS-IV (primary endpoint) and BSFQ (secondary endpoint) scores indicated improvement in ADHD manifestations throughout the day and before school, respectively.
Jornay PM, a CII controlled substance, will be supplied in 20mg, 40mg, 60mg, 80mg, and 100mg strength capsules. It is anticipated to launch in the first half of 2019.
For more information call (877) 215-9938 or visit IronshorePharma.com.