The U.S. Food and Drug Administration (FDA) has approved a new formulation of the stimulant medication methylphenidate called Jornay PM (from Ironshore Pharmaceuticals) for the treatment of ADHD in persons over 6 years of age. This medication is now available nationwide.
Jornay PM won FDA approval despite the existence of 13 other approved methylphenidate products because it fulfills the last unmet need in the medication treatment of ADHD: coverage during the first hours of the day.
In the early morning hours, demand for organization and efficiency is high. Parents face the difficulty of waking, feeding, and dressing their children – all without the beneficial effects of ADHD medication for parent or child. Even when a dose is taken immediately upon waking, the therapeutic blood levels are too low to be fully effective during the two hours after taking ADHD medications available before Jornay PM. Parents with ADHD had to manage hectic schedules and organize children, all while the family was without the benefit of ADHD medication.
Jornay PM is designed with a delayed release layer that allows the dose of medication to be taken the night before while delaying the absorption of the medication for a period of up to 10-12 hours. Thus, both children and adults wake up the next morning with a full therapeutic blood level of methylphenidate. The FDA approval trials demonstrated the unique ability of Jornay PM’s delayed release formulation to improve morning behavior and activities while the 2nd extended release portion of the formulation improves classroom attention and behavior throughout the balance of the day.
Jornay PM comes in 5 dosage strengths: 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg. The dosages of Jornay are significantly different from other methyphenidate formulations such that persons switching from another medication must fine-tune their dose specifically for Jornay. The side effects of the methylphenidate found in Jornay PM are the same as for any of the other methylphenidate delivery systems available on the market.
Ironshore Pharmaceuticals offers a coupon system that can potentially lower the cost of Jornay PM to as low as $30 per month. Physicians may offer coupons and they are available online at www.jornaypm.com