Health Care

FDA OKs first non-opioid treatment for opioid withdrawal

FDA OKs first non-opioid treatment for opioid withdrawal”

On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms.

The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from opioids. Lucemyra was approved to treat withdrawal symptoms for up to two weeks.

The medication may lessen the severity of withdrawal symptoms but not completely eliminate them. 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. Expanding access to treatment is viewed as an important step to curbing the country's increasing overdose rates. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.

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.

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. And those who seek assistance may relapse due to continued withdrawal symptoms. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments". These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. Its safety and how well it works is not known in people younger than 17.

The drug was tested in two clinical trials involving 866 adults dependent on opioids who abruptly stopped using the drugs. 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. Approval for the treatment was based on positive trial data that showed the medication significantly reduced the severity of withdrawal symptoms in comparison to placebo.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids. 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.

Lofexidine had fast-track designation and was reviewed under the FDA's priority review process. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.

Lucemyra (lofexidine hydrochloride), therefore, represents a win for both the agency and US WorldMeds, which has just a handful of marketed products.

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