On March 2, the US FDA has approved a new drug application (NDA) for AZSTARYS (code name: KP415), once a day, for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. Will be commercialized in the United States. To
AZSTARYS is a compound capsule dosage form composed of dexmethylphenidate (d-MPH) prodrug serdexmethylphenidate (SDX) and immediate release d-MPH. AZSTARYS contains 30% immediate release d-MPH and 70% extended release new SDX. After being absorbed through the gastrointestinal tract, SDX is converted to d-MPH, and d-MPH is gradually released within a day.
Compared with the currently marketed drugs Vyvanse (Ridexamphetamine Dimesylate Capsules) and Osmotic (Methylphenidate Hydrochloride Sustained Release Tablets), AZSTARYS has the advantage of immediate onset due to the immediate release of d-MPH. Compared with Adderall XR (amphetamine complex salt sustained-release capsules) and Focalin XR (dexmethylphenidate hydrochloride sustained-release capsules), because SDX is a prodrug, it can reduce drug dependence.
A multicenter, double-blind, randomized, placebo-controlled, phase III study (NCT03292952) evaluated the efficacy of AZSTARYS. The study recruited 150 children aged 6-12 years with a diagnosis of ADHD. The results of the study showed that compared with the placebo group, the symptoms of children in the AZSTARYS group were significantly improved, and the SKAMP-C score was reduced by an average of 5.4 points compared with the placebo group.
Since AZSTARYS contains d-MPH, which is a Class II controlled substance, the FDA recommends that AZSTARYS also be classified in accordance with Class II controlled substances. AZSTARYS will go on sale in the summer of 2021.
Post time: May-17-2021