Azstarys Approved to Treat ADHD

March 3, 2021 – The U.S. FDA has approved AzstarysTM (serdexmethylphenidate/dexmethylphenidate), manufactured by Corium, to treat attention deficit hyperactivity disorder (ADHD) in patients who are least six years of age.

ADHD is a neurodevelopmental disorder characterized by impulsive behavior, hyperactivity, and a lack of focus that interfere with daily life. Patients experience a range of symptoms and may not demonstrate all three characteristics. While often diagnosed in childhood, ADHD can continue into adulthood. The cause is not fully understood, and current treatment typically involves a combination of behavioral therapy and medication.

In a laboratory classroom study of children aged 6-12 years, Azstarys significantly improved ADHD symptoms with a single dose compared to placebo based on SKAMP-C scores (Swanson, Kotkin, Agler, M- Flynn, and Pelham Rating Scale – Combined). The SKAMP scale measures manifestations of ADHD by having an independent observer rate a participant's degree of impairment in classroom-observed behaviors. Azstarys treats ADHD by combining two central nervous system (CNS) stimulants – one for immediate release and another for extended release to help manage symptoms throughout the day. It is currently the only FDA-approved drug for ADHD that contains dexmethylphenidate.

Recommended initial dosing for patients 6-12 years of age is 39.2mg serdexmethylphenidate and 7.8mg dexmethylphenidate taken by mouth once each morning. The dosage can be increased to 52.3mg/10.4mg daily or decreased to 26.1mg/5.2mg daily after one week, based on patient response. In patients ages 13 and up, recommended initial dosing is 39.2mg/7.8mg once each morning. Recommended dosing after one week is 52.3mg/10.4mg once daily. Azstarys can be taken with or without food, and the capsules can be swallowed whole or broken open to mix the contents with applesauce or water. Azstarys should not be substituted for other methylphenidate products on a milligram-per-milligram basis due a risk of substitution errors and overdose.

A black box warning cautions that CNS stimulants – including Azstarys, other methylphenidate-containing products, and amphetamines – have a high potential for abuse and dependence. Prescribers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while the patient is taking Azstarys.

Azstarys is currently under review by the U.S. Drug Enforcement Administration (DEA) for controlled substance scheduling. It is expected to be designated a Schedule II controlled substance. This would put it in the same schedule as drugs such as morphine and methadone that have a currently accepted medical use, but a high potential for abuse.

Corium expects to launch the product in the summer of 2021, pending the DEA’s controlled substance scheduling decision.