FDA approves drug to help with opioid withdrawal symptoms

Maricruz Casares
May 17, 2018

The United States Food and Drug Administration (FDA) has approved a nonopioid drug called Lucemyra for the treatment of opioid withdrawal symptoms in adults. Physical dependence to opioids is an expected physiological response to opioid use.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine and its actions are believed to play a role in the symptoms of withdrawal. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. The biggest risk of experiencing severe symptoms is that the patient may be driven back into drug use.

The most common side effects from treatment include hypotension, bradycardia, somnolence, sedation and dizziness, and was also associated with a few cases of syncope. When Lucemyra is stopped, patients can experience a marked increase in blood pressure.

"Most opiate overdose deaths occur in people who have just detoxed".

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

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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.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

These come on within hours of a drug-dependent person stopping or cutting their dosage of opioids - whether it's prescribed or sought out for abuse. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

Opioids were involved in more than 42,000 overdose deaths in 2016, the past year for which data was available, according to the U.S. Centers for Disease Control and Prevention. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.

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