Catalent-made Lucemyra wins US FDA approval for opioid withdrawal
The US Food and Drug Administration (FDA) approved the first non-opioid treatment for the management of opioid withdrawal symptoms last week.
Contract manufacturing organisation (CMO) Catalent Pharma Solutions makes US WorldMeds’ Lucemyra (lofexidine hydrochloride) at its Winchester, Kentucky-based facility in the US. In the UK, Britannia Pharmaceuticals has sold lofexidine – marketed as BritLofex – since 1992.
While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them, according to the FDA. The oral, selective alpha 2-adrenergic receptor agonist – designed to reduce the release of norepinephrine – is approved for treatment for up to 14 days.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help,” said FDA commissioner Scott Gottlieb in a statement.
The American Society of Addiction Medicine (ASAM) told us it supports a “comprehensive approach” to addressing opioid misuse and the overdose epidemic, including medication options that help manage withdrawal symptoms.
“The FDA-approval of Lucemyra adds another tool to the toolbox for patients and practitioners considering opioid withdrawal management,” said ASAM Board secretary Yngvild Olsen.
“ASAM looks forward to collaborating with the FDA and other government agencies to promote advances in and increased access to therapies that can increase treatment options for patients with addiction," she added. “This would include research on novel approaches to managing opioid withdrawal."
