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FDA Approves First Drug to Combat Opioid Withdrawal Symptoms
The National Institute on Drug Abuse (NIDA) announced that the FDA has approved the first medication for use in reducing symptoms associated with opioid withdrawal in adults, lofexidine. The product will be marketed under the brand name Lucemyratm. Lucemyratm is expected to be commercially available in the United States in August 2018.
Lofexidine, an oral tablet, is designed to manage the symptoms patients often experience during opioid discontinuation. Opioid withdrawal symptoms, which can begin as early as a few hours after the drug was last taken, may include aches and pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning, and feeling sick, among others.
In 2016, more than 42,000 people died from an opioid overdose, or approximately 115 people per day. Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs. By alleviating symptoms associated with opioid withdrawal, Lucemyratm could help patients complete their discontinuation of opioids and facilitate successful treatment. To date, no other medications have been approved to treat opioid withdrawal symptoms.
Lucemyratm will be marketed by US WorldMeds, a specialty pharmaceutical company that acquired a license for lofexidine from Britannia Pharmaceuticals in 2003. NIDA provided funding to US WorldMeds to support clinical trials to document the clinical pharmacokinetics of lofexidine and to test medical safety and efficacy of the medication, as compared to a placebo, among patients undergoing medically supervised opioid discontinuation.
Reference: https://www.drugabuse.gov/news-events/news-releases/2018/05/fda-approves-first-medication-to-reduce-opioid-withdrawal-symptoms
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