|The following article is part of The Clinical Advisor’s coverage from the 2018 American Association of Nurse Practitioners’ annual meeting in Denver. Our staff will be reporting live on original research, case studies, and professional outreach and advocacy news from leading NPs in various therapeutic areas. Check back for ongoing updates from AANP 2018.|
DENVER — Lofexidine, a non-narcotic, alpha-2 adrenergic agonist historically used for the treatment of hypertension, may facilitate the discontinuation of opioids and treat opioid withdrawal symptoms in opioid-dependent individuals, according to research presented at the American Association of Nurse Practitioners (AANP) 2018 National Conference.
Carlos Tirado, MD, of CARMAhealth, LLC in Austin, Texas, and colleagues collected data from 2 phase 3 placebo-controlled studies of lofexidine treatments to compare symptoms of withdrawal in patients aged 18 years and older taking short-acting opioids.
The first study compared the efficacy of lofexidine 3.2 mg/d (0.8 mg 4 times daily) with placebo, while the second study compared the same dosage of lofexidine with a reduced dosage of 2.4 mg/d (0.6 mg/d).
The investigators invited 242 participants in the lofexidine group and 77 participants in the placebo group to complete the double-blind treatment and reported that individuals in the control groups of both studies stayed longer than those receiving placebo. The most frequently reported reasons for withdrawal from a study was consent withdrawn and lack of treatment effectiveness.
Significantly lower scores on the Short Opioid Withdrawal Scale of Gossop, used to measure withdrawal symptom intensity, were reported in both lofexidine groups compared with placebo; peak scores were also significantly lower for both groups compared with placebo.
Adverse events associated with treatment included hypotension (including orthostatic hypotension), bradycardia, dizziness, somnolence, dry mouth, and sedation. The frequency of serious adverse events was low in both participants receiving lofexidine (2.3%) and those receiving placebo (3.2%). The most serious adverse events occurred in patients who withdrew from the study prematurely.
Mark Pirner, MD, PhD, senior medical director of clinical research and medical affairs at US WorldMeds in Louisville, Kentucky, and coauthor of the study, stated in an interview with The Clinical Advisor, “the [US Food & Drug Administration’s] recent approval of [lofexidine] reiterates the encouraging results from the clinical trials and underscores the potential of this new medication to benefit people who want to discontinue opioid use and may struggle with the agonizing symptoms of opioid withdrawal.”
“We believe [lofexidine] is positioned to address an unmet medical need as an evidence-based treatment option for people who wish to better manage their withdrawal process and discontinue opioid use,” continued Dr Pirner. “As we work to improve outcomes for people affected by the opioid epidemic, [lofexidine] may play a critical role in helping people stay engaged and retained in treatment by mitigating opioid withdrawal symptoms.”
For more coverage of AANP 2018, click here.
Disclosure: This study was sponsored by the National Institute on Drug Abuse. Drs Pirner and Clinch are employees of US WorldMeds, LLC.
Tirado C, Pirner M, Clinch T. Lofexidine efficacy and safety in opioid withdrawal: pooled analysis of phase 3 studies. Presented at the American Association of Nurse Practitioners 2018 National Conference. June 29-July 1, 2018; Denver, CO. Poster 4.