A pharmaceutical company based in the Cayman Islands says it has developed the only stimulant medication to treat symptoms of Attention Deficit Hyperactivity Disorder that is dosed in the evening for effectiveness in early morning and throughout the day.
Ironshore Pharmaceuticals said in a press release the U.S. Food and Drug Administration approved the New Drug Application for the medication, JORNAY PM, in patients 6 years and older.
It expected to be available commercially in the first half of 2019. Ironshore says the medication may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.
David Lickrish, president and CEO, noted that some manufacturers adjusted the ratio of immediate-release and extended-release features in different formulations of methylphenidate to achieve an earlier onset.
“Our approach to drug development was to start from the desired pharmacokinetic profile and then work to develop a purpose-built technology capable of achieving that profile. I believe that the unique DELEXIS drug delivery platform is a disruptive technology that has many applications and opportunities in several therapeutic categories,” he said.
Ironshore, a wholly owned subsidiary of Highland Therapeutics, noted in the press release that CNS stimulants, including JORNAY PM, have a high potential for abuse and dependence.
According to research reports commissioned by Ironshore, control over the symptoms of ADHD during the early morning routine remains a significant concern for parents of children with ADHD.
As reported in the Journal of Child and Adolescent Psychopharmacology, a majority of surveyed parents of children with ADHD report that the symptoms associated with ADHD in the early morning are described as “moderate” or “severe” during this time period.
“Developing a drug using a different delivery technology that will provide an additional option for patients and the physicians who treat them takes time,” said Dr. Bev Incledon, head of research and development at Ironshore. “After 10 years of unrelenting determination, those efforts have finally been rewarded.”
Ironshore proved the effectiveness of JORNAY PM in two separate placebo-controlled studies conducted in 278 pediatric patients aged 6 to 12 years.
Dr. Randy Sallee, Ironshore’s chief medical officer, said, “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 moonshot solution to meeting this need.
“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,” Mr. Sallee added.