Azstarys medication is a prescription medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years and older. Just to recap, ADHD is a neurodevelopmental disorder that includes inattention, hyperactivity and impulsivity. As the result, these symptoms can make daily living even more complicated, that is they can cause significant reduction in academic performance and social interactions. Azstarys is a distinct medication combining serdexmethylphenidate with immediate-release dexmethylphenidate as an active ingredient.
Azstarys combines these two components in a unique way to deliver both acute and sustained symptom relief, so the product is pharmacokinetically able to work for up to 13 hours. This sustained effect is especially useful in children and adolescents who need continuous symptom control over their school hours as well the late afternoon evening period. Results from clinical studies have demonstrated that Azstarys improves attention and decreases both hyperactive/impulsive behaviors relative to placebo, starting at 1 hour post-administration.
This was seen in a key Phase 3 trial where the drug led to a 56% reduction in attention-deficit/hyperactivity disorder (ADHD) symptoms based on mean changes from baseline SKAMP (Swanson, Kotkin, Agler-Hill and M-Flynn-Pelham Scale), which is used to track outcomes of ADHD over time during standard clinical visits. The 150 children with ADHD had robust treatment response and excellent tolerability in this trial. Significant benefits in attention and behavior were seen early following the first dose, continued throughout the day, supporting Azstarys' effectiveness in managing ADHD symptoms.
The two-component solubility matrix of Azstarys fulfills an important unmet need in ADHD treatment by reducing the peaks and troughs related to IR stimulant medications. This class of agents is usually formulated as an immediate-release (IR) tablet that must often be dosed multiple times daily, potentially producing fluctuations in symptom control and offering new challenges to adherence. Azstarys offers a more sustained treatment effect, decreasing the need to take additional doses and thereby improving overall compliance with treatment.
The safety profile of Azstarys is similar to that seen with other stimulant medications. The most common adverse reactions are a decreased appetite, insomnia and an increased heart rate which tend to be mild. Discontinuation due to adverse events was relatively infrequent (approximately 4%) in clinical trials, suggesting most patients tolerate the medication well. When considering the prescription of Azstarys, healthcare providers will take these factors into account to determine optimal use for patient outcomes.
According to the Centers for Disease Control and Prevention (CDC), ADHD affects about 6.1 million children in the United States alone The approval of Azstarys represents a valuable addition to the therapeutic armamentarium for this vulnerable population, particularly those who are not symptomatically controlled on other medications. The evolution of Azstarys is representative of the continual progression in treating ADHD, with the goal to help enhance experiences and quality of life for those living with this disorder.
The approval of Azstarys by the U.S. Food and Drug Administration (FDA) in March 2021 was an important event for ADHS treatment. The recommendation followed a thorough review with the FDA looking at clinical trial data showing that it acts as intended. The approval of this agent demonstrates the value in offering efficacious and convenient treatment solutions to help those with ADHD manage their symptoms, in line with current clinical practice guidelines that stress individualized care for chronic conditions.
Patients should seek personalized advice from their specialist to receive more about Azstarys medicine and its purposes. The advent of Azstarys aligns with the promise offered by a developing new treatment class in ADHD that one day may fundamentally change outcomes and potential for routine living among people impacted by this devastating condition.