FDA Approves Azstarys, a Once-Daily Stimulant for ADHD
Key takeaways:
Azstarys was recently approved by the FDA to treat ADHD in people ages 6 years and older.
Azstarys is the first medication to contain serdexmethylphenidate and immediate-release dexmethylphenidate.
The developer of Azstarys expects the medication to be available this summer.
Attention-deficit hyperactivity disorder (ADHD) is one of the most common mental health conditions affecting children. And it can be diagnosed in adults, too. Finding the right medication to treat ADHD can be a process — sometimes you’ll need to try a few before you find one that works. But now, with Azstarys, you’ll have a new treatment that works differently compared to those currently on the market.
Azstarys is a new medication that the FDA recently approved to treat ADHD in people 6 years and older. This medication will be the first of its kind and will give healthcare providers another option for treating ADHD.
Below, we’ll discuss how Azstarys works, its side effects, and when it will be available to the public.
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What is Azstarys?
Azstarys is a once-daily capsule containing serdexmethylphenidate (SDX) and immediate-release dexmethylphenidate (d-MPH). It will be the first ADHD medication to combine these two ingredients.
In its phase 3 clinical trial — the last stage before seeking FDA approval — Azstarys improved attention and behavior for children between ages 6 and 12 better than placebo (a pill with no medication in it).
How does Azstarys work?
Azstarys is a central nervous system (CNS) stimulant. CNS stimulants make the brain more alert, which improves focus and attention. When a person takes Azstarys, the immediate-release d-MPH in the capsule is fully absorbed within about 2 hours, while the SDX ingredient is absorbed slowly over several hours. This means that it should kick in quickly and keep working all day long.
How will Azstarys be dosed?
Azstarys will be available in three strengths:
26.1 mg of SDX/5.2 mg of d-MPH
39.2 mg of SDX/7.8 mg of d-MPH
52.3 mg of SDX/10.4 mg of d-MPH
Azstarys should be taken once a day in the morning with or without food. Most people will start with the 39.2 mg/7.8 mg strength. Depending on how you respond to the medication, your provider may adjust your dose after a week of treatment. The maximum dose is 52.3 mg/10.4 mg once daily.
If you can’t swallow Azstarys capsules whole, you can open them and sprinkle the contents into 50 mL of water or on top of 2 tablespoons of applesauce. If you do this, be sure to consume this mixture within 10 minutes of preparing it.
What do we know about potential side effects?
Like other stimulants used to treat ADHD, Azstarys is a controlled substance. That means it can lead to physical dependence and can be easily misused. If you have a personal or family history of addiction, you may have a higher risk of this happening.
Those with heart problems have a higher risk of heart attacks with Azstarys. Let your provider know if you have a history of any heart issues, including high blood pressure. They may want to check in with you more regularly to make sure your heart is staying healthy enough to take this medication.
Common side effects of this medication include:
Lower appetite
Stomach upset
Trouble sleeping, especially if taken later in the day
Weight loss in children
Jitteriness and mood changes
Dizziness
Fast heart rate
Very rarely, Azstarys can cause priapism — a painful erection lasting longer than 4 hours that isn’t relieved by sex. If this happens, you should seek medical help right away, as it could cause permanent damage to your penis.
Can it interact with other medications?
Azstarys should not be taken at the same time as, or within 14 days of, stopping monoamine oxidase inhibitors (MAOIs) — a type of medication used to treat depression and Parkinson’s disease. Taking Azstarys and MAOIs together can lead to a severe rise in blood pressure that can be life-threatening.
Azstarys can also make blood pressure medications less effective. Ask your provider if you should regularly check your blood pressure at home while taking this medication.
Sometimes children being treated for ADHD with stimulants may also be taking another medication called risperidone (Risperdal) for behavioral issues. While using these medications together is relatively common, be aware that dose adjustments of either medication (or both) may raise the risk of movement changes (called extrapyramidal symptoms) like spasms, restlessness, and other uncontrolled movements.
Lastly, you’ll want to let your provider know about any medications you or your child are taking before surgery. This is a serious concern with Azstarys as it can interact with some of the gases used to put you under for a procedure, causing your blood pressure and heart rate to go up suddenly.
How does Azstarys compare to other ADHD medications?
Azstarys is unique because it contains both d-MPH and SDX in one capsule. So if you’re currently taking both a short-acting and long-acting stimulant, this medication might lower the number of pills you need to take in a day to treat your ADHD symptoms.
Currently, there are no studies directly comparing Azstarys to other ADHD medications, so we can’t say if it works better than available alternatives.
When will Azstarys be available?
Azstarys is expected to be available this summer. If you are wondering if this is a good option for you, discuss it with your provider at your next appointment. Let your pharmacist know if your provider is going to start prescribing it for you, as it may take a little longer to order it than other medications.
The bottom line
Azstarys is a central nervous system stimulant approved by the FDA in March 2021 to treat ADHD. It is unique because it is the first medication to combine dexmethylphenidate and serdexmethylphenidate. Because of this, Azstarys may offer all-day symptom relief with a single pill. It is expected to be available this summer.
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