US WorldMeds, LLC and Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, have entered into an exclusive agreement to co-promote US WorldMeds’ Lucemyra (lofexidine). The FDA approved Lucemyra on May 16, 2018 as the first and only non-opioid medication for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
Opioid withdrawal is an often-overlooked medical challenge in the current opioid epidemic, which has reached dangerous levels. More than 115 people in the United Statesdie each day after overdosing on opioid-based products, according to a 2017 report from the Centers for Disease Control and Prevention.1
“Partnering with Salix, which has a strong commercial presence in primary care and pain management, will provide greater momentum and broader reach for the launch and uptake of Lucemyra—including the critical need for education around opioid withdrawal and the appropriate use of Lucemyra,” said P. Breckinridge Jones, chief executive officer, US WorldMeds. “We look forward to making Lucemyra available to health care providers and their patients who urgently need help discontinuing opioid use.”
From a clinical standpoint, symptoms of withdrawal are one of the most powerful drivers of opioid dependence and addictive behaviors. Many people have such difficulty tolerating these symptoms that the desire to avoid them can perpetuate their opioid use.2
“Research indicates that withdrawal fear is contributing to the U.S. opioid public health issue.2 We believe an important step in addressing this epidemic is to empower patients with the ability to endure opioid withdrawal and provide a starting point towards recovery,” said Mark McKenna, senior vice president and general manager, Salix. “We have developed a national sales footprint in pain management with Relistor (methylnaltrexone bromide), a treatment for opioid-induced constipation, and with the addition of Lucemyra, we can now offer a second solution in our portfolio to address the complexities of treatment with opioid-based pain medications.”
The approval of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials, an open-label study and several clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone. The FDA reviewed the New Drug Application for Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
Lucemyra is expected to be commercially available in the United States in August.
2. Kosten TR, George TP. The Neurobiology of Opioid Dependence: Implications for Treatment. Science & Practice Perspectives. 2002;1(1):13-20.
(Source: US WorldMeds)