US WorldMeds has received approval from the US Food and Drug Administration (FDA) for the use of Lucemyra (lofexidine hydrochloride) to alleviate opioid withdrawal symptoms in adults.
The drug allows the management of abrupt discontinuation of opioids for up to 14 days and is the first approved non-opioid treatment for this indication.
It can mitigate the severity of withdrawal symptoms but may not be able to offer complete prevention.
Lucemyra is an oral, selective agonist of alpha 2-adrenergic receptor and is designed to minimise the release of norepinephrine, which is associated with several opioid withdrawal symptoms.
These withdrawal symptoms such as anxiety, sleep problems, muscle aches, sweating, nausea, vomiting, diarrhoea and drug craving occur in people with physical dependence on opioids.
This may include patients using prescribed opioids correctly as well as those with opioid use disorder (OUD).
While the drug has not been approved as a therapy for OUD, it can be a part of a long-term treatment plan for managing the condition.
FDA commissioner Scott Gottlieb said: “As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids.
“We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms.”
US WorldMeds submitted safety and efficacy data from two randomised, double-blind, placebo-controlled clinical trials involving 866 adults physically dependent on opioids and undergoing abrupt discontinuation.
Results showed that severity scores on the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) were lower for subjects treated with Lucemyra than those who received placebo.
The regulatory agency has instructed US WorldMeds to submit data from 15 animal and human post-marketing studies to ensure safety for long-term usage and use in paediatric patients.