Dual-action ADHD drug provides both early- and late-onset symptom relief

FDA has approved Azstarys (KemPharm), the first ADHD medication to combine two medications, 70% serdexmethylphenidate (SDX) and 30% immediate-release dexmethylphenidate (d-MPH), in a once-daily capsule for treatment of patients ages 6 years older. Because d-MPH is fully absorbed within about 2 hours, while SDX slowly over several drug provides both early onset action longer duration therapy.Dosing administrationAzstarys will be available three dosage strengths SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 52.3/10.4 mg.In children 12 years, recommended starting 39.2 mg/7.8 mg orally once daily morning, with or without food. The may increased maximum dose 52.3 mg/10.4 decreased 26.1 mg/5.2 after 1 week.For adults 13 17 morning. week daily.Patients who cannot swallow capsules whole can open sprinkle contents into 50 mL water onto tablespoons applesauce consume mixture 10 minutes preparation.Safety efficacyAzstarys's safety efficacy were evaluated multicenter, double-blind, randomized, placebo-controlled, laboratory classroom Phase III study 150 aged ADHD. Compared placebo, significantly improved symptoms single dose, as measured by primary endpoint: change from baseline SKAMP-C rating scale scores averaged 13-hour day. As improved, declined.The group had an average score reduction −5.4 points more than placebo group. Adverse events that occurred frequently (2% participants) compared headache (5.4% vs. 1.3%, respectively), upper abdominal pain (4.1% 1.3%), insomnia (2.7% sore throat 0%). No serious adverse reported.Boxed warning, effectsLike other CNS stimulants used treat ADHD, controlled substance comes boxed warning on high potential abuse dependence, particularly personal family history addiction. Providers should assess patients' risk before prescribing monitor signs dependence they are taking medication.Cardiovascular resulting sudden death have been reported pediatric structural cardiac abnormalities heart problems.In adults, death, stroke, myocardial infarction reported. Patients known abnormalities, cardiomyopathy, arrhythmias, coronary artery disease not use drug. blood pressure pulse consider benefits risks whom increase rate would problematic.Because associated long-term suppression growth, children's height weight monitored at appropriate intervals.Psychotic manic occur no psychiatric illness exacerbated preexisting illness. bipolar disorder being prescribed drug.Azstarys cause priapism—a painful erection lasting 4 hours. If this happens, seek medical help right away.Common effects include nausea, pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, pressure, tachycardia.Drug interactionsPatients MAOIs depression Parkinson's take same time 14 days stopping MAOI. combination severe, potentially life-threatening rise render medications less effective.In also risperidone, adjustments either (or both) raise spasms, restlessness, uncontrolled movements.Patients having surgery inform their provider any taking, interact anesthesia drugs rapid rate.AvailabilityBecause contains d-MPH, Schedule II stimulant, it classified substance. Pending final scheduling decision DEA, expected summer. therapy. Dosing preparation. mg. In week. For daily. Safety Azstarys's declined. Boxed tachycardia. Like medication. Cardiovascular problems. problematic. intervals. Psychotic away. Common Drug rate. effective. movements. AvailabilityBecause