FDA OKs first non-opioid drug for adults with opioid withdrawal symptoms
The United States Food and Drugs Administration (FDA), in a statement this week, approved a new drug Lucemyra (lofexidine hydrochloride) for the treatment and alleviation of opioid symptom withdrawal symptoms in adults in whom the drugs have been withdrawn abruptly.
The drug Lucemyra reduces the severity of withdrawal symptoms but cannot eliminate them altogether. The treatment is to be provided only for 14 days. The statement mentions that Lucemyra is not a treatment of opioid use disorder (OUD) but a part of its management.
FDA Commissioner Scott Gottlieb, M.D. in his statement 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. 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 FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments.”
At present the medications used in treatment of withdrawal symptom prevention include methadone, naltrexone, buprenorphine etc.
This new drug, Lucemyra is to be given orally. It is essentially a selective alpha 2-adrenergic receptor agonist. This drug acts by reduction of release of norepinephrine. When the norepinephrine release is reduced the symptoms may be eased. For approval the manufacturers submitted results of two randomized, double-blind, placebo-controlled clinical trials. These studies included a total of 866 adults who met the criteria for Diagnostic and Statistical Manual-IV criteria for opioid dependence and who were undergoing an abrupt opioid withdrawal process. The score used to test the efficacy of the drug was Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop). This was a patient-reported outcome instrument that could help patients report their symptoms after intake of the drug. Each of the symptoms were rated by the patients as either “none, mild, moderate and severe”. SOWS-Gossop total score ranged between 0 and 30. If the score was higher the symptoms of withdrawal was deemed higher. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo.
Side effects seen with Lucemyra use were low blood pressure, slow heart rate, sleepiness, dizziness. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias. It is not yet declared safe in children and adolescents up to the age of 17 years.
The symptoms of abrupt opioid withdrawal includes;
- Muscle pain
- Abdominal cramps
- Runny nose, sweating
- Nausea and vomiting
- Excessive yawning
- Intense drug craving
These are seen in individuals who have physical dependence on opioids and also occurs if the dose is reduced. For these individuals, to avoid symptoms medications need to be tapered slowly.
The FDA requires a further 15 postmarketing studies to check for the safety of the drug. At present the new drug has been granted Priority Review and Fast Track approval. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. The approval for making the drug is granted to US WorldMeds LLC.