The US Food and Drug Administration (FDA) has announced its approval of Lucemyra (lofexidine hydrochloride), the first non-opioid medication intended for the reduction of withdrawal symptoms associated with opioid use disorder (OUD) in adults, enabling patients’ discontinuation of opioid treatments.
Lucemyra, manufactured by pharmaceutical company US WorldMeds, is an alpha 2-adrenergic receptor agonist that decreases the release of norepinephrine, a hormone thought to cause many opioid withdrawal symptoms. The drug’s safety and efficacy was demonstrated by two placebo-controlled trials that enrolled 866 adults who were physically dependent on opioids.
In the trials, patient progression was measured using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which assesses opioid withdrawal symptoms based on patient-reported data. The studies found SOWS-Gossop scores to be lower for patients treated with Lucemyra compared to placebo, while more patients completed the treatment period of the studies in the Lucemyra group compared to the placebo group.
Lucemyra is not intended as a complete treatment for OUD, as it can only reduce the severity of withdrawal symptoms rather than prevent them entirely, and is only approved as a treatment for a maximum of 14 days. As such, it is intended for use as part of longer-term treatment routes.
“Today’s approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual’s needs,” FDA Division of Anesthesia, Analgesia and Addiction Products director Sharon Hertz said.
Opioid withdrawal typically causes psychological problems such as anxiety and agitation, as well as physical symptoms including muscle aches, nausea and vomiting. Such symptoms are seen in patients who have been using prescription opioids, as well as those with OUD.
Patients in the former category are usually treated by a slow taper off of the medication, while those with OUD are typically given a substitute opioid medication followed by a gradual transition to maintenance therapy using FDA-approved drugs such as methadone, buprenorphine or naltrexone.
“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,” FDA commissioner Scott Gottlieb said.
“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. And those who seek assistance may relapse due to continued withdrawal symptoms.”
The fast-tracked decision follows an independent FDA advisory committee report of the drug in March which concluded that it has a beneficial effect. The agency has requested 15 postmarketing studies – including both animal and human trials – as well as animal safety studies. The effect of Lucemyra on the liver and blood pressure will also be examined in the trials.