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18 May 2018, 09:30 | Louis Holland
FDA on Wednesday (May 16) approvedUS WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal.
In late-stage testing, patients physically dependent on opioids who abruptly quit taking them reported less severe withdrawal symptoms when taking Lucemyra compared to placebo. "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". Plus, more patients in the Lucemyra arm completed a seven-day opioid discontinuation treatment. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal. Safety and efficacy in patients younger than 17 has not been established, the agency noted.
The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. Patients can experience any combination of these symptoms after ceasing opioid use.
Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.
The drug helps with symptoms like vomiting, muscle pain, diarrhea and agitation.
Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments". These studies included a total of 866 adults who met the criteria for Diagnostic and Statistical Manual-IV criteria for opioid dependence and who were undergoing an abrupt opioid withdrawal process.
The agency is now requiring 15 postmarketing studies.
While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency.
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. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA.
Lucemyra was licensed by US WorldMeds in the early 2000s, Pirner said. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.
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