Ironshore Pharmaceuticals gets FDA nod for Jornay PM for ADHD
Ironshore Pharmaceuticals & Development has received the Food and Drug Administration's approval for Jornay PM (methylphenidate, formerly known as HLD200) for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 years and older.
The product is a novel formulation of methylphenidate which is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day, according to the company.
Jornay PM is the first drug utilizing Ironshore’s new drug delivery technology, which 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.
“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,” Ironshore president and CEO David Lickrish said, in a press statement.
The launch of Jornay PM is slated for the first half of 2019.
The product is a novel formulation of methylphenidate which is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day, according to the company.
Jornay PM is the first drug utilizing Ironshore’s new drug delivery technology, which 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.
“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,” Ironshore president and CEO David Lickrish said, in a press statement.
The launch of Jornay PM is slated for the first half of 2019.