FDA approves first non-opioid treatment for opioid withdrawal
18 May, 2018, 09:28 | Author: Andrea Terry
For people who have been diagnosed with opioid use disorder, withdrawal management alone, with or without Lucemyra, is not recommended; Lucemyra should be used as part of a long-term treatment plan created by a healthcare provider.
The non-opioid tablets can be used for up to two weeks.
The approval of WorldMed's Lucemyra was expedited in an effort to combat the opioid epidemic.
For those addicted to opioids, quitting cold turkey can be a harrowing experience. It treats narcotic withdrawal symptoms like vomiting, muscle aches, diarrhea, anxiety, sleep problems and sweats.
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.
Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions. And those who seek assistance may relapse due to continued withdrawal symptoms.
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.
The safety and efficacy was supported by 2 randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores were found to be lower for patients treated with Lucemyra, and more patients finished the treatment in the Lucemyra group versus the placebo group.
The FDA has requested 15 post-marketing studies, in both animals and humans, to support longer-term use of the drug and use in children or adolescents under 17. This committee received public input from patients who use opioids to manage their chronic pain. It is not approved as a treatment for opioid use disorder.
In patients utilizing opioid analgesics fittingly as endorsed, opioid withdrawal is regularly overseen by a moderate decrease of the prescription, which is planned to dodge or reduce the impacts of withdrawal while enabling the body to adjust to not having the opioid. Some patients received Lucemyra, and some patients received a placebo.
The new compound itself is not without side effects; Lucemyra can cause dizziness as well as low blood pressure and heart rate. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.
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