As part of the nation’s ongoing war against opioid epidemic, the U.S. Food and Drug Administration (FDA)’s Psychopharmacologic Drugs Advisory Committee has voted in favor (11 to 1) of approving LUCEMYRA (lofexidine) for managing opioid withdrawal symptoms. The committee has backed the approval to help individuals dependent on opioids get relief from acute withdrawal symptoms and prolong their stay in the treatment. If approved, the drug would be the first non-opioid medication to treat opioid withdrawal symptoms and the first to help patients successfully terminate their opioid discontinuation treatment.
LUCEMYRA can suppress the neurochemical surge that produces painful opioid withdrawal symptoms. As per the claims of the manufacturing company, the drug was found to be both safe and effective in reducing withdrawal symptoms that often discouraged patients from successfully completing their treatment. In the clinical trials, the drug was shown to significantly reduce the severity of the withdrawal symptoms. However, at present, LUCEMYRA is not approved in the United States and is in developmental phase.
According to Kristen Gullo, US WorldMeds’ vice president of development and regulatory affairs, the company is expecting FDA’s decision on the drug by May 26, 2018. The company also intends to work closely with FDA officials in determining labelling information and has plans to commission studies on tapering its use. If approved, US WorldMeds would launch the drug in the market this summer.
Ugly face of the opioid crisis
Opioid overdose (prescribed and illegal) claims more than 115 American lives every day. In fact, drug overdose has now emerged as the foremost cause of death for Americans. Opioid misuse has led to an increase in health care costs, loss of productivity, rise in treatments, and increase in criminal activities, drug seizures and incarceration rates. Opioid addiction has become a serious public health crisis that impacts social and economic fabric of the country.
Opioids are usually prescribed to treat moderate to severe pain associated with an injury, surgical procedure or terminal illness. They are also prescribed in cases of chronic pain like back or joint pain. When used as prescribed, opioids are safe and effective but with increased tolerance to the drug, many patients continue taking it even when they no longer need it. Lack of safe storage and disposal of opioids at home also increases the risk of their misuse among family members.
Abrupt stoppage of opioids may lead to acute withdrawal symptoms that can cause a relapse. While the amount, length and intensity of the symptoms differ from person to person, some of the common ones include intense cravings, nausea, vomiting, diarrhea, insomnia, sweating, muscle aches and cramps. The best way to come out of the vicious cycle is to gradually taper off the use until the opioids are no longer required and to get medication-assisted treatment (MAT), which gradually reduces dependence.
Road to recovery
A leading addiction treatment facility, Sovereign Health of California provides personalized treatment for patients’ safe rehabilitation. Treatment for drug addiction at our state-of-the-art rehab facilities takes a holistic and clinically informed approach that helps individuals make real life changes and learn effective coping strategies. Depending on an individual’s symptoms and medical history, treatment may involve a combination of detoxification, behavioral therapies and mind-relaxing techniques
For more information on our evidence-based recovery programs or to locate our drug addiction treatment center, call our live admission specialist at the 24/7 helpline number or chat online with our representative.