Adlon Therapeutics LP, a subsidiary of Purdue Pharma LP, reports the publication of post-hoc analyses of data from a randomized, double‑blind, forced‑dose, placebo‑controlled safety and efficacy study and a six‑month open‑label safety extension study of Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII in the journal CNS Drugs. The studies evaluated the effect of Adhansia XR on sleep in adults with attention-deficit/hyperactivity disorder (ADHD).
The full prescribing information for Adhansia XR contains a boxed warning emphasizing that central nervous system (CNS) stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence. Healthcare 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.
“As some adult patients with ADHD experience insomnia, there is considerable individual variability, and an identified need for more data on the effect of prescription ADHD stimulant medications on sleep,” says Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer, Purdue Pharma, in a release. “The data from this post hoc analysis adds to the growing body of knowledge around the relationship between sleep, ADHD, and prescription stimulant treatment and underscore our commitment to understanding the needs of patients with ADHD.”
A randomized, double-blind, forced-dose, placebo-controlled Phase 3 safety and efficacy study and a six-month open-label safety extension study of Adhansia XR in adult patients with ADHD assessed the effects of Adhansia XR on sleep quality as a secondary endpoint. At screening, baseline, end of double-blind study, and during monthly open-label visits, patients completed the Pittsburgh Sleep Quality Index (PSQI), which is used to measure indicators such as overall sleep quality, sleep latency, duration of sleep, sleep efficiency, sleep disturbances, requiring medication to sleep, and daytime disfunction due to sleepiness.
The double-blind study enrolled 375 adult patients with a DSM-5 ADHD diagnosis; 333 adults completed treatment. Patients were randomly assigned to a fixed daily dose of Adhansia XR at 25, 45, 70, or 100 mg for 2 weeks of titration and 2 weeks of maintenance on the randomized dose. One hundred and eight-four (184) adult patients who had completed the double-blind study participated In the six-month open-label extension study and were titrated to receive their optimal dose for six additional months (25, 35, 45, 55, 70, 85, or 100 mg).
In the double-blind study, PSQI Global Scores in the Adhansia XR treatment arm remained similar to placebo (Baseline Placebo, 8.4 ±3.7; Baseline Adhansia XR, 8.8±3.7; End of Double-Blind Placebo, 7.3±4.1; End of Double-Blind Adhansia XR, 8.1±3.6, p=.0972). During the open-label extension where patients were titrated to their optimum dose, the PSQI Global Scores decreased further from the baseline at six months (5.4±3.21). A lower PSQI Global score indicates better sleep quality.
The most common sleep-related adverse events (AEs) in the double-blind study were headache (Adhansia XR, 17.5%; placebo, 11.5%), insomnia (Adhansia XR, 15.8%; placebo, 3.8%) and decreased appetite (Adhansia XR, 11.1%; placebo, 2.6%) for all doses combined. Two patients in the Adhansia XR treatment arm were withdrawn from the double-blind study because of insomnia AEs. In the six-month open-label extension study, the most frequent adverse events were insomnia (15.1%), initial insomnia (11.9%), headache (10.8%) and decreased appetite (8.1%). One patient was withdrawn from the open-label extension study because of insomnia.
Adhansia XR is the only extended-release methylphenidate treatment for ADHD that provides an onset of action at 1 hour and duration of clinical effect throughout the day (up to 16 hours in adults) with a single daily dose. Adhansia XR capsules contain identical beads which are formulated using the proprietary smart design MLR (Multi-Layer Release) technology.
Adhansia XR is not appropriate for all patients, and healthcare professionals should 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.