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FDA approves first non-opioid medication for opioid withdrawal symptoms

by | May 17, 2018

In April, we reported in our blog about the potential approval by the U.S. Food and Drug Administration (FDA) of the first non-opioid medication to alleviate opioid withdrawal symptoms. Yesterday, the FDA approved Lucemyra™ (lofexidine hydrochloride) for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. Safety and efficacy has not been established in children and adolescents under the age of eighteen. Lucemyra may lessen the severity of symptoms, but may not completely prevent them. While this new medication does not specifically treat opioid use disorder (OUD), it may be used as part of an overall treatment plan to manage claimants with OUD.

Treatment with Lucemyra is only approved for up to fourteen days. However, the FDA has indicated that post-marketing studies will be required to assess use beyond fourteen days. 

As expected, Lucemyra will be marketed by US WorldMeds, LLC.  The company is planning to launch the 0.18 mg tablet in the United States in August 2018.

To learn more about this medication, click here.

Sources:

  1. U.S. Food and Drug Administration News Release. FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults. May 16, 2018. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607884.htm?utm_campaign=05162018_PR_FDA%20approves%20non%20opioid%20treatment%20for%20opioid%20withdrawals&utm_medium=email&utm_source=Eloqua. Accessed May 17, 2018.
  2. US WorldMeds. FDA Approves US WorldMeds’ LUCEMYRA™ (lofexidine) After Priority Review for the Management of Opioid Withdrawal Symptoms. May 16, 2018. Available at: https://www.multivu.com/players/English/8314851-us-world-meds-lucemyra-fda-approval/. Accessed May 17, 2018.
 

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