FDA approves first non-opioid medicine to help detox
18 May, 2018, 09:27 | Author: Cassandra Gardner
The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days.
For those addicted to opioids, quitting cold turkey can be a harrowing experience.
Patients who go off opioid painkillers face excruciating withdrawal symptoms such as anxiety, nausea, vomiting, insomnia, muscle aches and more.
Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy.
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"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said in a press release.
Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.
Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain.
Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. 866 adults participated in the study. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment". Lucemyra isn't a treatment for opioid utilize clutter (OUD), however, can be utilized as a feature of a more extensive, long haul treatment get ready for overseeing OUD.
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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.
On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms. Reported adverse side effects include low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth. Some patients received Lucemyra, and some patients received a placebo. Safety and efficacy in patients younger than 17 has not been established, the agency noted. 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. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly.
As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution.
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.
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