FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder
FDA approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD).
DETAILS: Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.
“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue to take the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.”
Buprenorphine is a safe and effective medication for the treatment of OUD. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), patients receiving medication for their OUD cut their risk of death from all causes in half.
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The FDA continues to implement a comprehensive approach to increase options to treat OUD. Earlier this month, the agency issued a joint letter with SAMHSA to clarify the importance of counseling and other services as part of a comprehensive treatment plan for OUD, and to also reiterate that supplying buprenorphine should not be made contingent upon participation in such services. The agency also held a virtual public workshop that highlighted the need for additional strengths and dosing regimens for extended-release formulations.
Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, 128 mg. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by health care providers in a health care setting.
The most common adverse reactions (occurring in >=5% of patients) with Brixadi include injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at the injection site (injection-site pruritus), insomnia and urinary tract infections.
The safety and efficacy of Brixadi were evaluated in a behavioral pharmacology study assessing the ability of two weekly doses of Brixadi to block the subjective effects of opioids, and one randomized, double-blind, active-controlled clinical trial in 428 adults with a diagnosis of moderate-to-severe OUD. After an initial test dose of transmucosal buprenorphine, patients were randomized to treatment with Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections. After titration over the first week, patients were treated with weekly injections over 12 weeks and then transitioned to monthly injections for an additional 12 weeks. A response to treatment was measured by urine drug screening and self-reporting of illicit opioid use during the treatment period. Patients were considered responders if they had negative opioid assessments at the end of each of the two treatment phases. The proportion of patients meeting the responder definition was 16.9% in the Brixadi group and 14.0% in the sublingual buprenorphine group.
The FDA granted approval of Brixadi to Braeburn Inc.
The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through its FDA Overdose Prevention Framework. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
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Source: FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder. FDA. Published: May 23, 2023.
Cannabis Use Disorder and Subsequent Risk of Psychotic and Nonpsychotic Unipolar Depression and Bipolar Disorder
This population-based cohort study found that CUD was associated with an increased risk of psychotic and nonpsychotic bipolar disorder and unipolar depression. These findings may inform policies regarding the legal status and control of cannabis use.
KEY FINDINGS: This population-based cohort study found that CUD was associated with an increased risk of psychotic and nonpsychotic bipolar disorder and unipolar depression. These findings may inform policies regarding the legal status and control of cannabis use.
BACKGROUND: Cannabis use is increasing worldwide and is suspected to be associated with increased risk of psychiatric disorders; however, the association with affective disorders has been insufficiently studied. Aim of this study was to examine whether cannabis use disorder (CUD) is associated with an increased risk of psychotic and nonpsychotic unipolar depression and bipolar disorder and to compare associations of CUD with psychotic and nonpsychotic subtypes of these diagnoses. This prospective, population-based cohort study using Danish nationwide registers included all individuals born in Denmark before December 31, 2005, who were alive, aged at least 16 years, and living in Denmark between January 1, 1995, and December 31, 2021.
DETAILS: The main outcome was register-based diagnosis of psychotic or nonpsychotic unipolar depression or bipolar disorder. Associations between CUD and subsequent affective disorders were estimated as hazard ratios (HRs) using Cox proportional hazards regression with time-varying information on CUD, adjusting for sex; alcohol use disorder; substance use disorder; having been born in Denmark; calendar year; parental educational level (highest attained); parental cannabis, alcohol, or substance use disorders; and parental affective disorders. A total of 6,651,765 individuals (50.3% female) were followed up for 119,526,786 person-years. Cannabis use disorder was associated with an increased risk of unipolar depression (HR, 1.84; 95% CI, 1.78-1.90), psychotic unipolar depression (HR, 1.97; 95% CI, 1.73-2.25), and nonpsychotic unipolar depression (HR, 1.83; 95% CI, 1.77-1.89). Cannabis use was associated with an increased risk of bipolar disorder in men (HR, 2.96; 95% CI, 2.73-3.21) and women (HR, 2.54; 95% CI, 2.31-2.80), psychotic bipolar disorder (HR, 4.05; 95% CI, 3.52-4.65), and nonpsychotic bipolar disorder in men (HR, 2.96; 95% CI, 2.73-3.21) and women (HR, 2.60; 95% CI, 2.36-2.85). Cannabis use disorder was associated with higher risk for psychotic than nonpsychotic subtypes of bipolar disorder (relative HR, 1.48; 95% CI, 1.21-1.81) but not unipolar depression (relative HR, 1.08; 95% CI, 0.92-1.27).
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Source: Jefsen, O. H., Erlangsen, A., Nordentoft, M., et al. (2023). Cannabis Use Disorder and Subsequent Risk of Psychotic and Nonpsychotic Unipolar Depression and Bipolar Disorder. JAMA Psychiatry. 2023; 80(8): 803-810. Published: August, 2023. DOI: 10.1001/jamapsychiatry.2023.1256.
Nitrous Oxide-Induced Myeloneuropathy
Preventable neurological harm from N2O abuse is increasingly seen worldwide. Ease of access to canisters and larger cylinders of N2O has led to an apparent rise in cases of N2O-myeloneuropathy in several areas of the UK.
KEY FINDINGS: Preventable neurological harm from N2O abuse is increasingly seen worldwide. Ease of access to canisters and larger cylinders of N2O has led to an apparent rise in cases of N2O-myeloneuropathy in several areas of the UK. The results highlight the range of clinical manifestations in a large group of patients to improve awareness of risk, aid early recognition, and promote timely treatment.
BACKGROUND: Nitrous oxide (N2O) is the second most common recreational drug used by 16- to 24-year-olds in the UK. Neurological symptoms can occur in some people that use N2O recreationally, but most information comes from small case series.
DETAILS: Authors describe 119 patients with N2O-myeloneuropathy seen at NHS teaching hospitals in three of the UK's largest cities: London, Birmingham and Manchester. This work summarises the clinical and investigative findings in the largest case series to date. Paraesthesia was the presenting complaint in 85% of cases, with the lower limbs more commonly affected than the upper limbs. Gait ataxia was common, and bladder and bowel disturbance were frequent additional symptoms. The mid-cervical region of the spinal cord (C3-C5) was most often affected on MRI T2-weighted imaging. The number of N2O canisters consumed per week correlated with methylmalonic acid levels in the blood as a measure of functional B12 deficiency (rho (ρ)=0.44, p=0.04).
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Source: Mair, D., Paris, A., Zaloum, S. A., et al. (2023). Nitrous Oxide-Induced Myeloneuropathy: A Case Series. Journal of Neurology, Neurosurgery & Psychiatry. 2023; 94(9): 681-688. Published: September, 2023. DOI: 10.1136/jnnp-2023-331131.
Psychosocial Interventions With Art and Music During Stem Cell Transplantation
Psychosocial interventions with art and music have improved the care and experience of patients undergoing stem cell transplant.
KEY FINDINGS: Several art and music interventions have been attempted which were beneficial to patients and generated a sense of achievement, connection and enjoyment. The interventions appear to uphold the principles of person-centred holistic care and have potential to generate a high-quality, supportive healthcare and working environment.
BACKGROUND: The objective of this study is to systematically review the literature with the following aims: to survey the art and music interventions offered to the stem cell transplant population; to define the interventions' beneficial properties by conceptualising themes; to analyse these themes using behavioural activation principles as a lens and explore their value in alleviating isolation-related distress. Patients undergoing stem cell transplant are at great risk of psychological morbidity, partly on account of prolonged hospital stays in protective isolation. This risk extends beyond discharge and into ambulatory care, negatively affecting quality-of-life and survival rates of the transplant recipients.
DETAILS: A systematic search of 10 bibliographic databases was undertaken using terms relating to art, music and stem cell transplantation for the years 2012 to 2019. Records were assessed for quality and risk-of-bias using a critical appraisal tool and following the PRISMA Systematic Review checklist to guide reporting. Studies were analysed narratively and thematically. The 16 papers were of mixed quality. Findings and treatment effects differed between and within studies. The beneficial attributes of the treatments were clustered and divided into two groups. The first consisted of intrinsic, patient-focussed factors: (1) Creative outlet or acquisition of a new skill; (2) achievement of normality; (3) mutual or peer-support; (4) relationship-building and (5) meaningful recreation, distraction and diversion. The second group considered extrinsic factors: (6) Improved communication; (7) enhanced spiritual care and (8) better healthcare experience.
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Source: Hickey, K. D., Farrington, N., Townsend, K., et al. (2023). Psychosocial Interventions With Art and Music During Stem Cell Transplantation: An Integrative Review. J Clin Nurs. 2023; 32(13-14): 2998-3014. Published: July, 2023. DOI: 10.1111/jocn.16512.
Cerebral Small Vessel Disease Progression and the Risk of Dementia
SVD progression precedes dementia and may causally contribute to its development. Slowing SVD progression may delay dementia onset.
KEY FINDINGS: Both baseline SVD severity and SVD progression were independently associated with an increase in risk of all-cause dementia over a follow-up of 14 years. The results suggest that SVD progression precedes dementia and may causally contribute to its development. Slowing SVD progression may delay dementia onset.
BACKGROUND: Cerebral small vessel disease (SVD) is considered the most important vascular contributor to cognitive decline and dementia, although a causal relation between its MRI markers and dementia still needs to be established. The authors investigated the relation between baseline SVD severity as well as SVD progression on MRI markers and incident dementia, by subtype, in individuals with sporadic SVD over a follow-up period of 14 years.
DETAILS: The study included 503 participants with sporadic SVD, and without dementia, from the prospective Radboud University Nijmegen Diffusion Tensor and Magnetic Resonance Cohort (RUN DMC) study, with screening for baseline inclusion conducted in 2006. Follow-ups in 2011, 2015, and 2020 included cognitive assessments and MRI scans. Dementia was diagnosed according to DSM-5 criteria and stratified into Alzheimer’s dementia and vascular dementia. Results: Dementia as an endpoint was available for 498 participants (99.0%) and occurred in 108 participants (21.5%) (Alzheimer’s dementia, N=38; vascular dementia, N=34; mixed-etiology Alzheimer’s dementia/vascular dementia, N=26), with a median follow-up time of 13.2 years (interquartile range, 8.8–13.8). Higher baseline white matter hyperintensity (WMH) volume (hazard ratio=1.31 per 1-SD increase, 95% CI=1.02–1.67), presence of diffusion-weighted-imaging-positive lesions (hazard ratio=2.03, 95% CI=1.01–4.04), and higher peak width of skeletonized mean diffusivity (hazard ratio=1.24 per 1-SD increase, 95% CI=1.02–1.51) were independently associated with all-cause dementia and vascular dementia. WMH progression predicted incident all-cause dementia (hazard ratio=1.76 per 1-SD increase, 95% CI=1.18–2.63).
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Source: Jacob, M. A., Cai, M., van de Donk, V., et al. (2023). Cerebral Small Vessel Disease Progression and the Risk of Dementia: A 14-Year Follow-Up Study. Am J Psychiatry. 2023; 180(7): 508-518. Published: July, 2023. DOI: 10.1176/appi.ajp.20220380.
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