The Food and Drug Administration (FDA) on Wednesday approved a medication to lessen the side effects of opioid withdrawal in an effort to help mitigate what Commissioner Scott Gottlieb called "one of the biggest barriers" for those deciding to seek treatment.
Lucemyra is an oral medication that reduces the release of norepinephrine, which is believed to be associated with opioid withdrawal symptoms. The statement mentions that Lucemyra is not a treatment of opioid use disorder (OUD) but a part of its management. "We are humbled to bring to market the first and only non-opioid treatment for the mitigation of withdrawal symptoms - and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment".
In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. Before, people going through detox were given opioids which can be very addictive. Lucemyra is now only approved for no more than 14 days of treatment. 866 adults participated in the study. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use.
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"Which is why patients may often not be able to go through the process without being an inpatient". 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. Less common reactions could include fainting and abnormal heart rhythms. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse. The agency also is requiring 15 additional postmarketing studies to assess longer-term use and use in children and newborns. Concentrates in pediatric patients will incorporate investigations of babies with neonatal opioid withdrawal and investigations of various age gatherings of youngsters who have opioid withdrawal identified with ceasing therapeutically recommended opioid drugs.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.