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. The statement mentions that Lucemyra is not a treatment of opioid use disorder (OUD) but a part of its management.
Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.
The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal.
"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said in a press release. Before, people going through detox were given opioids which can be very addictive. Lucemyra was approved to treat withdrawal symptoms for up to two weeks. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction".
One form of medication-assisted treatment requires that a person have already gone through detox, which is when withdrawal symptoms occur. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.
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The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. The score used to test the efficacy of the drug was Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop).
Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns. Each of the symptoms were rated by the patients as either "none, mild, moderate and severe". If the score was higher the symptoms of withdrawal was deemed higher.
SOWS-Gossop scores were lower for patients treated with Lucemyra versus placebo and more patients in the Lucemyra group completed the treatment period.
Side effects of the treatment included low blood pressure, dizziness, sleepiness, slow heart rate, and a few cases of syncope (fainting). Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. Physical dependence to opioids is an expected physiological response to opioid use. For these individuals, to avoid symptoms medications need to be tapered slowly. The FDA has required another 15 studies to assess the drug's safety in situations not described in the current approval, including use in children and use that exceeds 14 days. The FDA reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The approval for making the drug is granted to US WorldMeds LLC.
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