Research & Development
US WorldMeds wins US FDA's approval for LUCEMYRA for management of opioid withdrawal symptoms
17 May 2018 -

Pharmaceutical company US WorldMeds reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for LUCEMYRA for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults following priority review, with expected launch in August 2018.

The company said LUCEMYRA (lofexidine) suppresses the neurochemical surge that produces the painful opioid withdrawal symptoms, aches/pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning and feeling sick.

LUCEMYRA (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal, added the company.

This US FDA's approval of LUCEMYRA is based on the company's two randomised, double-blind, placebo-controlled clinical trials, an open-label study and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone. The participants treated experienced less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid discontinuation treatment compared to placebo.

According to the company, LUCEMYRA is usually administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids); total treatment may continue for up to 14 days.