FDA Approves 1st Non-Opioid Treatment For Withdrawal

Expedited approval intended to combat national opioid crisis

Robert Mangino
May 17, 2018 - 7:14 pm

US WorldMeds


PITTSBURGH (NewsRadio 1020 KDKA) – The FDA approved the first non-opioid treatment for opioid withdrawal Wednesday.

Regulators fast-tracked the approval of lofexidine to combat the opioid epidemic. It will be sold by Kentucky-based US WorldMeds under the name Lucemyra.

The pill was approved for up to two weeks of treatment of withdrawal symptoms in adults, and can be used in longer-term treatment plans.

Gateway Rehab Medical Director Dr. Neil Capretto told the KDKA Radio Afternoon News Thursday this is a step in the right direction for combatting addiction.

“We definitely need more tools in our tool box,” Dr. Capretto said. “We’re seeing the worst drug epidemic we’ve ever seen leading to record numbers of overdose deaths devastating the lives of thousands of families and individuals in our community.” 

Dr. Capretto says withdrawal symptoms can occur after only a month of using opioids, and can include vomiting, muscle pain and anxiety. These symptoms- or even the fear of them – can prevent people struggling with addiction from quitting for good.  

“They try to stop and they get these severe symptoms and they go back and they just continue to progress,” Dr. Capretto said. “To reduce these withdrawal symptoms, it increases their chances of more comfortably and safely coming off of opioids.”

Currently, patients are often weaned off of addictive drugs with safer opioid medications such as methadone.

Testing will continue for younger and pregnant patients. Side effects of Lucemyra include low blood pressure, sleepiness, slower heart rate and dizziness. No price has been set.