Posted from: Monday, September 17, 2018 - 12:08 PM - Present

Jornay PM Approved to Treat ADHD

August 9, 2018 – The U.S. FDA has approved Jornay PM™ (methylphenidate) extended-release capsules, manufactured by Ironshore Pharmaceuticals, to treat attention-deficit hyperactivity disorder (ADHD) in children who are least six years of age. The product uses proprietary Delexis® technology to slow drug absorption in the body, and is the first ADHD stimulant medication that can be given at night.

According to the manufacturer, Jornay PM should ideally be taken at 8:00pm, but the medication can be taken any time between 6:30pm and 9:30pm for optimal effect. This allows parents to incorporate ADHD medication schedules with the evening routine, and can provide symptom relief for patients in the early morning.

The medication’s extended release formula is designed with two coatings. The first coating delays delivery of methylphenidate, the active ingredient, for up to 10 hours. Once the first coating has been broken down in the body, the second coating allows a controlled release of methylphenidate throughout the day. Recommended dosing is 20mg once per day to start. The dosage can then be titrated up once per week if needed, to a maximum of 100mg per day.

Methylphenidate is considered a Schedule II controlled substance, and Jornay PM carries black box warning that cautions patients and caregivers of the risk of abuse and dependence associated with central nervous system (CNS) stimulants like methylphenidate.

Ironshore plans to launch the product in 2019, but has not announced pricing plans.

Last Updated Friday, October 19, 2018 - 01:30 AM.