The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for JORNAY PM (methylphenidate) (formerly known as HLD200) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older.

JORNAY PM is a novel formulation of methylphenidate that is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. JORNAY PM is the first drug utilizing the proprietary drug delivery platform DELEXIS of Ironshore Pharmaceuticals & Development Inc, a wholly owned subsidiary of Highland Therapeutics Inc.

Ironshore plans to initiate the commercial launch of JORNAY PM in the first half of 2019.

David Lickrish, Ironshore president and CEO says in a release, “Some manufacturers have 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.”

DELEXIS is a novel and proprietary drug delivery technology that contains two functional film coatings that act synergistically to achieve a unique pharmacokinetic profile. The first layer delays the initial release of drug for up to 10 hours while the second layer helps to control the rate of release of the active pharmaceutical ingredient throughout the day.

Randy Sallee, PharmD, MD, chief medical officer at Ironshore, says, “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. 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.”

CNS stimulants, including JORNAY PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.