FDA Approves Non-Opioid Treatment for Opioid Withdrawal

18 May, 2018, 09:25 | Author: Denise Dawson
  • FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

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.

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

The national opioid epidemic has put a spotlight on the need for more treatments for pain, withdrawal symptoms and addiction.

The medicine is only approved to treat adults with withdrawal symptoms for up to 14 days. Less common reactions could include fainting and abnormal heart rhythms. In its announcement, US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal". It is not yet declared safe in children and adolescents up to the age of 17 years.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine and its actions are believed to play a role in the symptoms of withdrawal.

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Typical patients will receive three tablets taken orally four times a day at five- to six-hour intervals during the period of peak withdrawal symptoms. Patients' symptoms were evaluated according to the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.

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.

Lofexidine Hydrochloride, also referred to as the brand name Lucemyra, is now FDA Approved. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.

"Which is why patients may often not be able to go through the process without being an inpatient".

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. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. 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.

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