LUCEMYRA (Lofexidine) Now Available to Reduce Opioid Withdrawal Symptoms

MedicalResearch.com Interview with:

Mark Pirner, MD, PhD Senior Medical Director Clinical Research and Medical Affairs US WorldMeds

Dr. Mark Pirner

Mark Pirner, MD, PhD
Senior Medical Director
Clinical Research and Medical Affairs
US WorldMeds

MedicalResearch.com: What is the background for this announcement? How does lofexidine differ from other opioid withdrawal medications?

Response: LUCEMYRA™ (lofexidine) was FDA-approved on May 16 as the first and only non-opioid, non-addictive medication for the management of opioid withdrawal in adults.
LUCEMYRA mitigates the acute and painful symptoms of opioid withdrawal by suppressing the neurochemical surge in the brain that occurs when opioids are abruptly discontinued.

In clinical studies, patients receiving treatment with LUCEMYRA experienced greater symptom relief and were significantly more likely to complete their withdrawal. LUCEMYRA is not an opioid drug and is not a treatment for opioid use disorder; it should be used as part of a longer-term treatment plan.

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Can Opioid Users Be Transitioned To Extended-Release Naltrexone?

MedicalResearch.com Interview with:

Dr. Maria Sullivan MD PhD Senior Medical Director of Clinical Research and Development Alkermes

Dr. Sullivan

Maria Sullivan, M.D., Ph.D
Senior Medical Director of Clinical Research and Development
Alkermes

MedicalResearch.com: What is the background for this study?

Response: Extended release injectable naltrexone is approved for the prevention of relapse to opioid dependence after detoxification and when used with counseling. It is recommended that patients abstain from opioids for a minimum of seven to 10 days prior to induction onto XR-naltrexone to avoid precipitating opioid withdrawal. This requirement of detoxification represents a substantial clinical challenge, particularly in the outpatient setting.

There is currently no single recognized best method for opioid detoxification prior to first dose of extended-release naltrexone (XR-naltrexone). A number of induction regimens have been explored, including the use of low doses of oral naltrexone to shorten the transition period from dependence on opioids to XR-naltrexone treatment. The goal of the study was to help establish an outpatient regimen to transition subjects from physiological opioid dependence to XR-naltrexone treatment and mitigate the severity of opioid withdrawal symptoms.

We hypothesized that low-dose oral naltrexone, combined with buprenorphine and psychoeducational counseling, would assist with the transition of patients with opioid use disorder onto XR-naltrexone. In this 3-arm trial, we examined the utility of oral naltrexone, buprenorphine, and a fixed regimen of ancillary medications (oral naltrexone + buprenorphine vs. oral naltrexone + placebo buprenorphine vs. placebo +placebo), to determine whether any of these regimens was associated with higher rates of induction onto XR-naltrexone.

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LUCEMYRA, First Drug for Opioid Withdrawal Symptoms, Receives FDA Recommendation

MedicalResearch.com Interview with:
http://usworldmeds.com/
Mark Pirner, MD, PhD
Senior Medical Director
US WorldMeds  

MedicalResearch.com: What is the background for this study? Would you briefly explain how lofexidine works?

Response: LUCEMYRA (lofexidine) was studied in two phase 3 pivotal randomized, double-blind, placebo-controlled clinical studies, and a phase 3 open-label study. Clinical pharmacology studies included evaluation of drug-drug interaction studies that demonstrated lofexidine can be safely administered concomitantly with methadone, buprenorphine or naltrexone.

LUCEMYRA is an alpha 2 adrenergic receptor agonist that reduces the surge of norepinephrine signaling in the brain which results from abrupt opioid withdrawal, and thereby reduces the severity of opioid withdrawal symptoms.  Continue reading