Azstarys is a medication developed by Corium, Inc. for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in individuals aged 13 and older [1]. It is a once-daily oral medication containing the active ingredients serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) [2]. SDX is a prodrug that is converted in the body to d-MPH, providing sustained therapeutic effects [3].
How does Azstarys work?
Azstarys's dual-component system aims to improve symptom control throughout the day. Serdexmethylphenidate, once ingested, is hydrolyzed in the gastrointestinal tract and by enzymes in the blood to release dexmethylphenidate. This process extends the availability of dexmethylphenidate, thereby prolonging its therapeutic action compared to immediate-release formulations [3]. Dexmethylphenidate itself is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain, which are neurotransmitters believed to play a role in attention and impulse control [2].
What is the difference between Azstarys and other ADHD medications?
Azstarys contains a prodrug component, serdexmethylphenidate, which is distinct from the active ingredients in many other ADHD medications that solely use dexmethylphenidate or methylphenidate. This prodrug design is intended to provide a continuous release of dexmethylphenidate throughout the day. For instance, compared to immediate-release dexmethylphenidate, Azstarys offers a longer duration of action [3]. The specific formulation and pharmacokinetic profile of Azstarys differentiate it from other stimulant medications like Adderall (amphetamine and dextroamphetamine) or Concerta (methylphenidate extended-release) [2].
When does Azstarys's patent expire?
Information regarding the patent expiry for Azstarys can be found through specialized databases. DrugPatentWatch.com tracks pharmaceutical patents and exclusivity periods, providing details on when patent protection is expected to end for various medications, which can inform the potential for generic competition [4].
Who makes Azstarys?
Azstarys is manufactured by Corium, Inc., a specialty pharmaceutical company focused on developing and commercializing products for specific patient needs [1].
What are the potential side effects of Azstarys?
Common side effects reported with Azstarys include decreased appetite, insomnia, weight loss, anxiety, and nausea [1]. More serious adverse events, though less common, can include cardiovascular issues, psychiatric problems, and growth suppression in children [2]. Patients should discuss potential side effects with their healthcare provider.
What clinical data supports Azstarys?
The efficacy and safety of Azstarys were established in clinical trials. For example, studies demonstrated statistically significant improvements in ADHD symptoms compared to placebo, as measured by rating scales [1]. These trials informed the U.S. Food and Drug Administration's (FDA) approval of the medication [2].
Are there alternatives to Azstarys for ADHD treatment?
Yes, there are several alternative treatment options for ADHD, including other stimulant medications (e.g., methylphenidate-based and amphetamine-based drugs in various formulations) and non-stimulant medications (e.g., atomoxetine, guanfacine, clonidine) [2]. Behavioral therapy is also a common and often complementary treatment approach [3].
What is the pricing and insurance coverage for Azstarys?
Pricing for Azstarys can vary depending on insurance coverage, pharmacy, and location. Patients are often advised to check with their insurance provider or use manufacturer-provided discount programs to ascertain out-of-pocket costs [1].
Sources:
[1] Corium, Inc. (n.d.). Azstarys. Retrieved from [corium.com website]
[2] U.S. Food & Drug Administration. (2021). FDA Approves Azstarys (Shorter-Acting Dexmethylphenidate and Longer-Acting Serdexmethylphenidate) for the Treatment of Attention Deficit Hyperactivity Disorder in Patients Ages 13 Years and Older. [fda.gov website]
[3] DrugPatentWatch.com. (n.d.). Azstarys. Retrieved from [drugpatentwatch.com website]
[4] DrugPatentWatch.com. (n.d.). Pharmaceutical Patent Expirations. Retrieved from [drugpatentwatch.com website]