FDA Approves First Non-Opioid Medicine For Opioid Withdrawal Symptoms (VIDEO)


The U.S. Food and Drug Administration recently approved a treatment that would potentially manage opioid withdrawal symptoms in adults, a move that could be beneficial in the Santa Clarita Valley, according to local rehab officials.

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Lucemyra is the first FDA approved non-opioid treatment for the management of opioid withdrawal symptoms. The drug provides a new option that allows providers to work with patients to select the treatment best suited to an individual’s needs, according to Dr. Sharon Hertz, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research.

In Santa Clarita, officials are hopeful about the new treatment.

“Any medications that are going to be utilized for opioid use against craving it is going to be beneficial,” said Bob Sharits, program director of The Wayout Recovery SCV, a Santa Clarita rehab center.

While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

“When they get on the medication, some of them will think ‘now that I’m on the medication, everything is going to be fine and I don’t have to do the other therapeutic methods,” Sharits said. “But if you’re going to take those medications, they are best taken in conjunction as other therapeutic methods.”

Opioid withdrawal includes symptoms — such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving — that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids, according to the FDA.

“When a person comes off of an opioid, one of the biggest obstacles to their recovery is the withdrawal symptoms,” said Sharits.

A majority of opioid abusers are between the ages of 18 and 30, Sharits said. Although the treatment is not for opioid use disorder, it can be used as part of a long-term treatment plan for managing the disorder.

“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” said Scott Gottlieb, the FDA commissioner. “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.”

Some of the common side effects from treatment with Lucemyra include low blood pressure, slow heart rate, sleepiness, sedation, dizziness and fainting.

Physical dependence to opioids is an expected physiological response to opioid use. These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with opioid use disorder, according to the federal agency.

Although the FDA has approved the treatment, it is requiring 15 postmarketing studies, including both animal and human studies that will be required to support longer-term use and use in children.

Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is currently approved, according to the federal agency.

Studies will also include newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs.

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