Upon approval by the Food and Drug Administration (FDA), Lofexidine would be the first non-narcotic and non-addictive medication approved in the United States for the mitigation or relief of symptoms associated with acute withdrawal from short-acting opioids such as heroin and commonly used prescription pain medications like Vicodin®, Lortab®, and Oxycontin®.
Lofexidine is approved in the United Kingdom as BritLofex® and has been used in successful detoxification of more than 200,000 opiate addicts. US WorldMeds acquired the U.S. license for Lofexidine from Britannia Pharmaceuticals in 2003. Lofexidine has also been studied in six prior clinical trials in the United States, including an earlier Phase III study of 264 opiate-dependent patients.
Currently, investigators are recruiting opiate-dependent individuals seeking detoxification at 13 sites throughout the United States. The Phase III trial is a randomized, double-blind, placebo controlled investigation evaluating the safety and efficacy of Lofexidine in the treatment of opioid-withdrawal symptoms.
In collaboration with National Institute on Drug Abuse (NIDA), US WorldMeds will continue to address an unmet medical need in the opioid-dependent population. The number of heroin abusers in the United States is estimated between 600,000 and 1 million. In addition, the United States Substance Abuse and Mental Health Services Administration recently reported that an estimated 22.5 million Americans, aged 12 or older, had used an illicit drug in the last month.1 According to the National Institutes of Health (NIH), this growing population of illicit drug users "accounts for $181 billion in health care, productivity loss, crime, incarceration and drug enforcement."2
Only two FDA-approved drugs, methadone and buprenorphine, are currently available to treat opioid withdrawal. Both are opiate products that effectively operate as replacement or substitution therapies, but both have abuse potential and are controlled substances. Since both options are scheduled drugs, this limits the number of licensed detoxification centers and/or licensed practitioners available to individuals seeking treatment. Many opiate addicts lack access to such care. Lofexidine would provide a new treatment option to those struggling with addiction as the first approved non-addictive, non-narcotic treatment to help patients manage debilitating withdrawal symptoms associated with opiate detoxification such as vomiting; sweating; stomach cramps; diarrhea; and muscle pain. These distressing physical symptoms can be major impediments for those who want to end their addictions.
Please refer to the News Room page for more information on Lofexidine.
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