What exactly is Azstarys?

Azstarys is a once-daily capsule containing serdexmethylphenidate (SDX) and dexmethylphenidate (IR) (d-MPH). It will be the first ADHD medication to include both of these ingredients.

Azstarys improved attention and behavior in children aged 6 to 12 better than placebo in a phase 3 clinical trial, the final stage before seeking FDA approval (a pill with no medication in it).

How does Azstarys function?

Azstarys is a stimulant of the central nervous system (CNS). CNS stimulants raise the alertness of the brain, which improves focus and attention. When a person takes Azstarys, the immediate-release d-MPH in the capsule is completely absorbed in about 2 hours, whereas the SDX ingredient is absorbed slowly over several hours. This means it should work quickly and continuously throughout the day.

How will Azstarys be administered?

Azstarys will be available in three different potencies:

SDX (26.1 mg/5.2 mg d-MPH)

39.2 mg SDX/ 7.8 mg d-MPH

SDX 52.3 mg/10.4 mg d-MPH

Azstarys should be taken in the morning, with or without food. Most people will begin with the 39.2 mg/7.8 mg dose. After a week of treatment, your provider may adjust your dose based on how you respond to the medication. The maximum daily dose is 52.3 mg/10.4 mg.

If you find it difficult to swallow Azstarys capsules whole, open them and sprinkle the contents into 50 mL of water or on top of 2 tablespoons of applesauce. If you do this, make sure to eat it within 10 minutes of preparing it.

What do we know about the possible side effects?

Azstarys, like other stimulants used to treat ADHD, is a controlled substance. That is, it has the potential to cause physical dependence and is easily abused. You may be at a higher risk if you have a personal or family history of addiction.

Azstarys increases the risk of heart attacks in people who already have heart problems. Inform your provider if you have a history of heart problems, including high blood pressure. They may want to check in with you more frequently to ensure that your heart is still in good enough shape to take this medication.