FDA Approves Drug to Ease Symptoms of Opioid Withdrawal

FDA Approves Drug to Ease Symptoms of Opioid Withdrawal

Ronald Pratt
May 18, 2018

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday. Plus, patients who got Lucemyra were more likely to complete the course of treatment, which can only last for up to 14 days.

Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time. It is essentially a selective alpha 2-adrenergic receptor agonist.

We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs.

The treatment had fast-track designation and was reviewed under the FDA's priority review process.

While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency. Regulatory approval was based on two randomized, double-blind, placebo-controlled clinical trials, an open-label study, and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone, according to the company release.

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"Lucemyra offers new hope to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal", said P. Breckinridge Jones, chief executive officer and founder of US WorldMeds.

Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Lucemyra effect the heart's electrical activity, which can increase the risk of abnormal heart rhythms. Patients can experience any combination of these symptoms after ceasing opioid use. Some patients received Lucemyra, and some patients received a placebo. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent.

The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17.

The FDA is requiring 15 postmarketing studies, including both animal and human studies. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.