The FDA noted that while Lucemyra can reduce withdrawal symptoms, it has not been confirmed to prevent them, and that the treatment should not continue beyond 14 days.
For those addicted to opioids, quitting cold turkey can be a harrowing experience. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.
"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms", said FDA Commissioner Scott Gottlieb, MD. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder.
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The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo.
The FDA said its decision to approve the drug was supported by data gathered from two clinical studies involving 866 clinically opioid-dependent adults, following abrupt discontinuation of use.
Sublocade is approved to treat opioid abuse disorder, but it also contains opioids itelf.
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"Which is why patients may often not be able to go through the process without being an inpatient".
On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms.
The most common side effects from treatment with Lucemyra include hypotension (low blood pressure), bradycardia (slow heart rate), somnolence (sleepiness), sedation and dizziness.
The safety and efficacy have not been established in children or adolescents 17 years of age and younger.
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The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. 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.