MedicalResearch.com Interview with:
Mark Pirner, MD, PhD
Senior Medical Director
Clinical Research and Medical Affairs
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.
MedicalResearch.com: What are the main indications and potential side effects?
Response: LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. LUCEMYRA’s overall safety profile reflects its mechanism of action, with side effects related to its pharmacological class. In clinical studies, the most common side effects of LUCEMYRA included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, feeling faint at rest or when standing up, sleepiness, and dry mouth. 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.
MedicalResearch.com: What should readers take away from your report?
Response: Many people have such difficulty tolerating opioid withdrawal symptoms that the desire to avoid them can perpetuate opioid use. A better understanding of opioid withdrawal therefore represents an opportunity in the prevention, treatment and recovery process for opioid dependence and opioid use disorder (OUD). LUCEMYRA can support people in their individual journey to recovery, which always includes completing withdrawal.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: LUCEMYRA is now commercially available by prescription across the United States. Additionally, US WorldMeds and Salix Pharmaceuticals have entered into an agreement to co-promote LUCEMYRA, fulfilling the critical need for education around opioid withdrawal and ensuring appropriate prescribing of LUCEMYRA by healthcare providers across the country
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