FDA Approves First Non-Opioid Treatment to Manage Withdrawal

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.

"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", said Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement.

The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal. Before, people going through detox were given opioids which can be very addictive. "But for places and people where withdrawal is perpetuating higher opioid use, then Lucemyra is an appropriate therapy".

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".

The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid epidemic, The Associated Press reported.

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Symptoms of opioid withdrawal vary.

Studies in pediatric patients will be conducted on newborns with neonatal opioid withdrawal and studies of various age groups of children with opioid withdrawal related to stopping medical-prescribed opioid drugs. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores were found to be lower for patients treated with Lucemyra, and more patients finished the treatment in the Lucemyra group versus the placebo group. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias.

Sublocade is approved to treat opioid abuse disorder, but it also contains opioids itelf.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions.

(Copyright © 2015. All Rights Reserved.)
 
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