4:41 PM
 | 
May 16, 2018
 |  BC Extra  |  Company News

FDA approves US WorldMeds' Lucemyra for opioid withdrawal

FDA approved Lucemyra lofexidine from US WorldMeds LLC (Louisville, Ky.) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. According to the agency, Lucemyra is the first non-opioid drug approved by FDA to manage opioid withdrawal symptoms.

US WorldMeds did not respond to inquiries regarding its launch plans or pricing details.

The oral agonist of adrenergic receptor alpha 2 (ADRA2) is approved for treatment up to 14 days since it may lessen withdrawal symptom severity but not completely prevent withdrawal symptoms. The drug is not approved to treat opioid use disorder but can be used as part of a treatment strategy for managing the disorder.

FDA said it is requiring 15 postmarketing studies of Lucemyra, including studies in children and animals to support longer-term use.

In March, FDA's Psychopharmacologic Drugs Advisory Committee voted 11-1 recommending approval of Lucemyra's NDA, which had Priority Review.

US WorldMeds obtained U.S. rights to lofexidine from Britannia Pharmaceuticals Ltd. in 2003. Britannia, which Stada Arzneimittel AG (Xetra:SAZ) acquired in 2007, markets the drug in the U.K. as BritLofex.

On Monday, FDA announced that the agency will hold a public meeting July 9 to discuss drug development for chronic pain. FDA Commissioner Scott Gottlieb said that as FDA learns about how chronic pain is managed, the agency can "balance between policies that allow appropriate prescribing for those in true need of these medicines and preventing unnecessary exposure to opioids that can increase the rate of new addiction" (see BioCentury Extra, May 14).

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