FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

The opioid addiction market got a new player Wednesday with the FDA approval of Lucemyra, a pill that helps patients manage symptoms of withdrawal.

In 2016, two-thirds of drug overdose deaths in the United States involved opioids - mostly fentanyl, heroin and prescription painkillers - the FDA said.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

The drug helps with symptoms like vomiting, muscle pain, diarrhea and agitation.

The U.S. Nourishment and Drug Administration has endorsed the main nonopioid treatment to enable grown-ups to oversee opioid withdrawal side effects as the organization hopes to keep on encouraging the advancement of treatments to help patients experiencing dependence.

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"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.

The safety and efficacy of Lucemyra was validated in two randomized, double-blind, placebo-controlled clinical trials of 866 adults who were physically dependent on opioids and undergoing abrupt opioid discontinuation. The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief. Lucemyra works by reducing the release of norepinephrine, a chemical in the body believed to play a part in withdrawal symptoms.

The drug Lucemyra reduces the severity of withdrawal symptoms but can not eliminate them altogether.

The FDA requires a further 15 postmarketing studies to check for the safety of the drug. 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 studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-reported outcome instrument that assesses opioid withdrawal symptoms. Patients abusing the drugs can suffer more severe withdrawal symptoms, and those who intend to take Vivitrol or another addiction drug need to withdraw from opioids first. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.

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