US WorldMeds and Salix Announce U.S. Launch of LUCEMYRA™ (lofexidine) 0.18 Mg Tablets
Published: Aug 06, 2018
LOUISVILLE, Ky. and BRIDGEWATER, N.J., Aug. 6, 2018 /PRNewswire/ -- US WorldMeds, LLC and Salix Pharmaceuticals, Ltd., a wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), today 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.
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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, 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. "We share US WorldMeds' enthusiasm and confidence that LUCEMYRA can help the millions who develop Opioid Withdrawal Syndrome find meaningful relief."
The launch includes a co-pay program that provides LUCEMYRA to eligible patients for as little as $25.† Most pharmacies across the country are covered through the program.
Physicians, pharmacists or other healthcare providers with questions about LUCEMYRA should contact 1-833-LUCEMYRA or visit www.lucemyra.com.
LUCEMYRA is not an opioid drug and is not a treatment for Opioid Use Disorder (OUD) (sometimes known as opioid addiction). For people who have been diagnosed with OUD, withdrawal management alone, with or without LUCEMYRA, is not recommended; LUCEMYRA should be used as part of a comprehensive management program created by a healthcare provider.
Important Safety Information for Patients
After a period of not using opioids, you may be more sensitive to the effects of lower amounts of opioids. Taking opioids in amounts that you used before stopping opioid use, whether with or without LUCEMYRA, can lead to overdose and death. It is important that you, your family, and the people closest to you are aware of this increased risk of overdose.
Alcohol, barbiturates, and benzodiazepines should be used with caution while taking LUCEMYRA as serious side effects may occur.
Tell your healthcare provider if you have ever been diagnosed with kidney disease or liver disease.
LUCEMYRA may cause low blood pressure or slower heart rate. Tell your healthcare provider if you have ever been diagnosed with low blood pressure, slow heart rate, any other cardiac abnormality (including prior diagnosis or family history of long QT syndrome), or if you have had a heart attack.
Tell your healthcare provider about all medications you are taking. LUCEMYRA should be used with caution with any medications that decrease pulse or blood pressure.
Watch for signs of a drop in your blood pressure or heart rate, including dizziness, lightheadedness, or feelings of faintness either when sitting or if you quickly stand up. If you experience these symptoms, call your healthcare provider and do not take your next dose of LUCEMYRA until you have talked to your healthcare provider.
It is important to stay hydrated while taking LUCEMYRA during opioid discontinuation or withdrawal.
The most common side effects seen with LUCEMYRA are low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth.
Talk to your healthcare provider before taking other medications for individual symptoms of withdrawal (such as pain relievers, sleep aids, or medications for upset stomach). Your healthcare provider will tell you whether it is safe to take LUCEMYRA with other medications you may be prescribed during opioid discontinuation (such as buprenorphine/naloxone, methadone, naltrexone).
LUCEMYRA should not be stopped abruptly. Consult your healthcare provider before stopping or reducing your LUCEMYRA dose.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-833-LUCEMYRA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here to access the full U.S. Prescribing Information and Patient Information for LUCEMYRA.
About LUCEMYRA (lofexidine)
About Opioid Withdrawal
About US WorldMeds
About Bausch Health
Under License from Britannia Pharmaceuticals Limited.
†Patients whose prescriptions will be paid for in part or in whole by Medicare, Medicaid or any similar federal or state healthcare program are not eligible for savings or rebates according to federal and state law. Patients must visit a participating pharmacy for savings or rebates on their LUCEMYRA prescriptions. Maximum benefits may apply.
US WorldMeds Media Contact: Bausch Health Investor Contact: Brittany Horowitz Arthur Shannon Brittany.Horowitz@edelman.com Arthur.Shannon@bauschhealth.com 646-229-0213 514-856-3855 877-281-6642 (toll free) Bausch Health Media Contact: Lainie Keller Lainie.Keller@bauschhealth.com 908-927-0617 US WorldMeds U.S. Medical Inquiries: Salix Media Contact: 888-900-USWM (8796) Karen Paff Karen.Paff@salix.com 908-927-1190
SOURCE US WorldMeds, LLC
Company Codes: NYSE:BHC, Toronto:BHC