FDA approves drug to help with opioid withdrawal symptoms

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

The U.S. Sustenance and Drug Administration today affirmed Lucemyra (lofexidine hydrochloride) for the alleviation of withdrawal side effects to encourage unexpected suspension of opioids in grown-ups.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said. 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.

Opioid withdrawal incorporates indications for example - uneasiness, unsettling, rest issues, muscle hurts, runny nose, sweating, sickness, spewing, loose bowels and medication wanting - that happens in the wake of ceasing or lessening the utilization of opioids in anybody with physical reliance on opioids. The approved treatment period is up to 14 days. Expanding access to treatment is viewed as an important step to curbing the country's increasing overdose rates. The medication was approved for use for up to two weeks, the FDA said.

Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy.

Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests. And those who seek assistance may relapse due to continued withdrawal symptoms. Common side effects include a slow heart rate, low blood pressure, and sleepiness. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

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US WorldMeds anticipates it can have its opioid withdrawal medication available to help patients by August.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

The FDA said its decision to approve the drug was supported by data gathered from two clinical studies involving 866 clinically opioid-dependent adults, following abrupt discontinuation of use. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder. Data from the Phase III study revealed that those treated with Lucemyra showed a significant reduction in withdrawal symptoms and demonstrated a longer stay in detoxification treatment when compared to individuals in the placebo group. 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. Animal safety studies will look at the drug's longer-term use and its use in children, the agency said. Since last April, when the Department of Health and Human Services announced its five-point plan for tackling the opioid crisis, just one novel pain treatment has gained FDA approval: Flexion Therapeutics' Zilretta (triamcinolone acetonide extended-release), a non-opioid option for osteoarthritis knee pain.

The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.

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