The drug's approval was based on 4 clinical studies evaluating the efficacy and safety of Adhansia XR in 883 people who met DSM-5 criteria for ADHD. Â
Officials with the FDA have approved methylphenidate hydrochloride (Adhansia XR, Adlon Therapeutics) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
The drug's approval was based on 4 clinical studies evaluating the efficacy and safety of Adhansia XR in 883 people who met DSM-5 criteria for ADHD. While receiving Adhansia XR, adults achieved statistically significant improvement over placebo, achieving greater mean Permanent Measure of Performance Total (PERMP-T) scores averaged across all time points on simulated Adult Workplace Environment (AWE) days (post-dose score of 281.3 vs. 254.5; difference of 26.80, 95% CI [15.19, 38.41]). The secondary efficacy endpoints were onset and duration of clinical effect, as assessed by the treatment difference in PERMP-T scores at post-dose time points. Adhansia XR demonstrated statistically significant improvement over placebo at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.
In the double-blind, randomized, placebo-controlled crossover AWE study, 10% of Adhansia XR-treated patients discontinued due to adverse reactions compared to 0% of placebo-treated patients. The following adverse reactions led to discontinuation at a frequency of 2% of Adhansia XR-treated patients: nausea, bronchitis, viral gastroenteritis, viral infection, increased blood pressure, and hypomania.
The Full Prescribing Information for Adhansia XR contains a boxed warning for abuse and dependence. CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence. Health care professionals should assess the risk of abuse prior to prescribing Adhansia XR and monitor for signs of abuse and dependence while patients are on therapy.
Adhansia XR will be available in 6 capsule strengths (25, 35, 45, 55, 70, and 85 mg), but it is not approrpriate for all patients. Health care professionals are urged to work with their patients to determine the most appropriate treatment option. Additionally, Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or product components, as well as patients receiving concurrent treatment with a monoamine oxidase inhibitor (MAOI) or who have used an MAOI within the preceding 14 days.
According to the National Institute of Mental Health and the CDC, medications for ADHD should be used as a part of a total treatment program that may include psychotherapy, education or training, or a combination of treatments.
Only a healthcare professional can diagnose ADHD, and diagnosis requires a comprehensive patient evaluation. Diagnostic criteria is provided in the American Psychiatric Association’s Diagnostic and Statistical Manual, Fifth edition (DSM-5).
This article was originally published atPharmacy Times.