FDA Approves First Nonopioid Treatment for Opioid Withdrawal Symptoms
- Author: Delores Daniels May 18, 2018,
May 18, 2018, 9:26
The FDA approved the first non-opioid treatment for opioid withdrawal symptom management in adults.
Lucemyra is an orally available alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, a neurotransmitter that plays a key role in many opioid withdrawal symptoms. Lucemyra is similar to clonidine, which FDA staff had noted in discussing the drug with an advisory committee in March, is often used off-label for 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.
For patients using opioids appropriately, withdrawal is usually managed by slow reduction in doses.
Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition.
The FDA granted this application both priority review and fast track designations. For approval the manufacturers submitted results of two randomized, double-blind, placebo-controlled clinical trials. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal. 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.
Sublocade is approved to treat opioid abuse disorder, but it also contains opioids itelf. 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. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms.
The agency is now requiring 15 postmarketing studies. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse.
The FDA still wants Lucemyra to conduct some safety studies to see the effects on children. The drug has not been evaluated in people under age 17, the FDA said.
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 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.