Elvium Life Sciences Announces Publication of New Data Analysis from Studies with FOQUEST® Controlled Release Capsules Examining Sleep Quality Outcomes in Adults with ADHD
Toronto, Ontario, August 25, 2021 – Elvium Life Sciences, an independent associated company of Purdue Pharma (Canada), announced the publication of post-hoc analyses of data from a randomized, double‑blind, 4-week, forced‑dose, placebo‑controlled safety and efficacy study and a six‑month open‑label safety extension study of FOQUEST® (methylphenidate hydrochloride controlled release capsules indicated for the treatment of Attention Deficit Hyperactivity Disorder in patients ≥6 years of age) in the journal CNS Drugs[i]. The secondary analysis of these studies evaluated the effect of FOQUEST on sleep in adults with Attention Deficit Hyperactivity Disorder (ADHD).
In the double-blind study, Pittsburgh Sleep Quality Index (PSQI) Global Scores in the FOQUEST treatment arm remained similar to placebo (Baseline Placebo, 8.4 ±3.7; Baseline FOQUEST, 8.8±3.7; End of Double-Blind Placebo, 7.3±4.1; End of Double-Blind FOQUEST, 8.1±3.6, p=.0972). However, 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 relationship between sleep and ADHD is complex and multifactorial with a higher prevalence of sleep problems being reported in adults with ADHD compared to those without. There is a need to better understand this relationship and the considerable individual variability that is observed by physicians treating ADHD,” said Dr. Atul Khullar, associate clinical professor of psychiatry at the University of Alberta and sleep specialist. “The data from this post hoc analysis adds to the growing body of knowledge around ADHD and sleep as well as the effects of treating ADHD with prescription stimulants on sleep outcomes. This is valuable information that will help physicians better understand how stimulant treatment may lead to changes in sleep quality in their ADHD patients.”
The article, “Effect of a Multi‑Layer, Extended‑Release Methylphenidate Formulation (PRC‑063) on Sleep in Adults with ADHD: A Randomized, Double‑Blind, Forced‑Dose, Placebo‑Controlled Trial Followed by a 6‑month Open‑Label Extension,” authored by Margaret D. Weiss, MD, Ph.D., FRCP(C); Craig Surman, MD; Atul Khullar, MD, MSc, FRCPC, DABPN; Ellie He, PhD; Marc Cataldo, PharmD; and Graeme A.E. Donnelly, MS, is available at this link.
Detailed Information About the Studies
A randomized, double-blind, 4-week, forced-dose, placebo-controlled phase three safety and efficacy study and a six-month open-label safety extension study of FOQUEST in adult patients with ADHD assessed the effects of FOQUEST 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 dysfunction 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 FOQUEST at 25, 45, 70, or 100 mg for 2 weeks of titration and 2 weeks of maintenance on the randomized dose. One hundred and eighty-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).
The most common sleep-related adverse events (AEs) in the double-blind study were headache (FOQUEST, 17.5%; placebo, 11.5%), insomnia (FOQUEST, 15.8%; placebo, 3.8%) and decreased appetite (FOQUEST, 11.1%; placebo, 2.6%) for all doses combined. Two patients in the FOQUEST 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.
See the full Canadian product monograph for FOQUEST.
The Product Monograph for FOQUEST contains a Serious Warning and Precaution for drug dependence, emphasizing that abuse of FOQUEST can lead to dependence. Healthcare professionals should assess the risk of abuse prior to prescribing FOQUEST, including in patients with a history of drug dependence or alcoholism, and monitor for signs of abuse and dependence while patients are on therapy.[ii]
FOQUEST is a once-daily, long-acting methylphenidate controlled-release capsule that has an onset of action within one hour and has a duration that manages symptoms throughout the day. Available in seven capsule strengths, FOQUEST allows for flexible dosing and offers a sprinkle option for patients who have difficulty swallowing capsules.ii The capsules have a patented multi-layer release, or MLR®, delivery system which allows for both a rapid initial release and a controlled release of medication throughout the day. The maximum daily dose of FOQUEST for children and adolescents (6 to <18 years old) is 70mg, and the maximum daily dose for adults (≥18 years old) is 100 mg.
Adverse events observed with FOQUEST treatment mainly reflect side effects commonly associated with methylphenidate use. Very common adverse events reported by patients treated with FOQUEST were headache, insomnia, decreased appetite and abdominal pain. Most of the events were mild to moderate in severity.ii
About MLR® Bead Technology
The MLR® (multi-layer release) technology is a unique controlled-release delivery system patented by Purdue Pharma (Canada). MLR® capsules are composed of multi-layered beads. The first layer is a coating of immediate-release, or IR, methylphenidate (20%), followed by specialized inner layers that act by delaying the release of additional medication, after which the remaining dose of methylphenidate (80%) is released in a controlled manner.ii
About Elvium Life Sciences
Elvium Life Sciences is an independent associated company of Purdue Pharma (Canada), that focuses on specialty pharmaceutical products committed to providing treatment options for patients who suffer from the symptoms of Attention Deficit/Hyperactivity Disorder (ADHD). For more information, please visit www.elvium.ca.
Purdue Pharma (Canada)
Purdue Pharma (Canada) is a privately held pharmaceutical company. Purdue Pharma (Canada) has an innovative product portfolio of prescription and non-prescription medications. Purdue Pharma (Canada) is a member of the Mundipharma network of independent associated companies.
For more information please contact:
[i] Weiss M. D. et al. Effect of a Multi‑Layer, Extended‑Release Methylphenidate Formulation (PRC‑063) on Sleep in Adults with ADHD: A Randomized, Double‑Blind, Forced‑Dose, Placebo‑Controlled Trial Followed by a 6‑month Open‑Label Extension” CNS Drugs. (2021); 35:667–679
[ii] FOQUEST® (methylphenidate hydrochloride controlled release capsules) Product Monograph, August 20, 2020