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17 May 2018, 11:42 | Randall Craig
Lucemyra is a drug for management of opioid withdrawal symptoms | Courtesy of US WorldMeds
"The fear of experiencing withdrawal symptoms often prevents those suffering from opioidaddiction from seeking help", Gottlieb said in a press release. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters.
US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal".
The drug Lofexidine, marketed as Lucemyra, will be the first non-opioid treatment for managing withdrawal symptoms. 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. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. Treatment may continue for up to 14 days and should be discontinued gradually over 2-4 days.
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, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said. The activities of norepinephrine in the autonomic sensory system are accepted to assume a part in a significant number of the side effects of opioid withdrawal. Some patients received Lucemyra, and some patients received a placebo. When treatment is stopped, patients can experience a marked increase in blood pressure.
The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function.
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.
The approval of WorldMed's Lucemyra was expedited in an effort to combat the opioid epidemic. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.
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.
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