The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry suspension, developed by US firms Tris Pharma and Pediatrix Therapeutics, has been awarded priority review status for use in attention deficit hyperactivity disorder (ADHD). The drug falls into the category of “new varieties, dosage forms, and specifications of children’s medicines in line with children’s physiological characteristics.”
Background and Previous Approvals
The central nervous system (CNS) stimulant was first approved in the US in December 2015 as the first chewable sustained-release tablets for ADHD. In a related development, the companies’ methylphenidate hydrochloride sustained release chewable tablets obtained priority review status in China in July of this year.
Future Outlook
The priority review status granted by the CDE highlights the potential of Tris Pharma and Pediatrix Therapeutics’ methylphenidate hydrochloride to address the needs of children with ADHD in China. This move is expected to expedite the drug’s availability in the Chinese market, providing a new treatment option for patients.-Fineline Info & Tech
