Sleep Treatments | Sleep Review
Adlon Therapeutics LP, a subsidiary of Purdue Pharma LP, announces the publication of post-hoc analysis of data from a randomized, double-blind, placebo-controlled safety and efficacy study with compulsory dosing and a six-month open label safety extension study of Adhansia XR (methylphenidate hydrochloride) prolonged-release capsules CII in the journal CNS Drugs. The studies looked at the effects of Adhansia XR on sleep in adults with attention deficit / hyperactivity disorder (ADHD).
The full prescribing information for Adhansia XR includes a boxed warning that emphasizes that central nervous system (CNS) stimulants, including Adhansia XR, other products containing methylphenidate, and amphetamines, have 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 being treated.
“As some adult patients with ADHD experience insomnia, there are significant individual differences and an identified need for more data on the effects of prescription ADHD-stimulating drugs on sleep,” said Julie Ducharme, BPharm, MSc, PhD, Vice President and Scientific Head of Officer, Purdue Pharma, in a press release. “The data from this post-hoc analysis complements our growing knowledge of the relationship between sleep, ADHD and prescription stimulants and underscores our commitment to understanding the needs of patients with ADHD.”
A phase 3 randomized, double-blind, placebo-controlled, forced-dose safety and efficacy study and a six-month open label safety extension study of Adhansia XR in adult patients with ADHD evaluated the effects of Adhansia XR on sleep quality as a secondary endpoint. At screening, baseline, end of double-blind study, and 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, sleep duration, sleep efficiency, sleep disorders, the Need for medication to help you sleep and daytime disturbances due to drowsiness
The double-blind study enrolled 375 adult patients diagnosed with DSM-5 ADHD; 333 adults completed treatment. Patients were randomly assigned to a fixed daily dose of 25, 45, 70 or 100 mg Adhansia XR for 2 weeks of titration and 2 weeks of maintenance dose of the randomized dose. One hundred and eighty-four (184) adult patients who completed the double-blind study enrolled in the six-month open label extension study and were titrated to their optimal dose for an additional six months (25, 35, 45, 55). , 70, 85 or 100 mg).
In the double-blind study, the 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 = 0.0972). During the open-label extension, in which patients were titrated to their optimal dose, the PSQI global scores continued to decline from baseline after 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 combined doses. Two patients in the Adhansia XR treatment arm were excluded from the double-blind study because of AEs of insomnia. In the six-month open-label extension study, the most common side effects were insomnia (15.1%), initial insomnia (11.9%), headache (10.8%), and decreased appetite (8.1%). One patient was excluded from the open-label extension study because of insomnia.
Adhansia XR is the only methylphenidate sustained release treatment for ADHD that provides onset of action after 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 formulated using proprietary Smart Design MLR (Multi-Layer Release) technology.
Adhansia XR is not suitable for all patients and healthcare professionals should work with their patients to determine the most appropriate treatment option. In addition, Adhansia XR is contraindicated in patients with known hypersensitivity to methylphenidate or product components, as well as in patients concomitantly treated with a monoamine oxidase inhibitor (MAOI) or who have used an MAOI within the last 14 days.
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