US WorldMeds, LLC. and Salix Pharmaceuticals, a wholly owned subsidiary of Bausch Health Companies Inc. announced the U.S. launch and availability of Lucemyra (lofexidine) 0.18 mg tablets, the first and only non-opioid medication indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
The Centers for Disease Control and Prevention estimates that more than 115 people in the U.S. die each day from opioid overdose.1 Often overlooked, opioid withdrawal is one of the most powerful barriers keeping people from discontinuing opioids. Many people have such difficulty tolerating symptoms of withdrawal that the desire to avoid them can perpetuate their opioid use.2 In a survey of people with chronic pain, 57 percent of patients reported avoidance of withdrawal as the primary reason for continued use of prescription opioids.3
“Many people who wish to stop taking opioids are searching for a treatment that will help get them through the agonizing symptoms of withdrawal,” said P. Breckinridge Jones, chief executive officer and founder, US WorldMeds. “The availability of Lucemyra broadens the range of evidence-based pharmacological options available to healthcare providers, so they can manage the challenges of withdrawal and facilitate their patients’ abrupt discontinuation of opioids.”
The FDA approved Lucemyra in May 2018. The product’s development involved a grant from and close collaboration with the National Institute on Drug Abuse, part of the National Institutes of Health. In June, US WorldMeds and Salix Pharmaceuticals entered into an exclusive co-promotion agreement for Lucemyra.
Today, Salix and US WorldMeds have initiated sales force efforts in the promotion of Lucemyra to primary care physicians, pain management specialists, and psychiatrists focused on addiction medicine and addictionologists.
“Lucemyra addresses a large and growing need in the field of primary care and pain management. Opioid withdrawal is frequently overlooked and can present a significant challenge in the discontinuation of opioid-based pain medications. By effectively intervening during withdrawal and helping to control severe, disabling withdrawal symptoms, Lucemyra can help provide a starting point toward recovery,” said Mark McKenna, president, Salix Pharmaceuticals.
- CDC/NCHS, National Vital Statistics System, Mortality. CDC Wonder, Atlanta, GA: US Department of Health and Human Services, CDC; 2017. https://wonder.cdc.gov.
- Kosten TR, George TP. The Neurobiology of Opioid Dependence: Implications for Treatment. Science & Practice Perspectives. 2002;1(1):13-20.
- Weiss RD. J Subst Abuse Treat. 2014 August; 47(2): 140–145. doi:10.1016/j.jsat.2014.03.004.
Filed Under: Drug Discovery