FDA Commissioner Scott Gottlieb commented on the approval, saying, "as part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids". Patients can experience any combination of these symptoms after ceasing opioid use. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use. While Lucemyra may diminish the seriousness of withdrawal side effects, it may not totally avert them and is affirmed for treatment for up to 14 days.
Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately be overcoming addiction.
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Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added.
For patients using opioids appropriately, withdrawal is usually managed by slow reduction in doses. Lucemyra works by reducing the release of norepinephrine, a chemical in the body believed to play a part in withdrawal symptoms.
To test the drug, researchers conducted a pair of random clinical trials. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo. Lucemyra isn't a treatment for opioid utilize clutter (OUD), however, can be utilized as a feature of a more extensive, long haul treatment get ready for overseeing OUD.
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The most widely recognized symptoms from treatment with Lucemyra incorporate hypotension (low circulatory strain), bradycardia (moderate heart rate), drowsiness (lethargy), sedation and wooziness. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias.
The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. Announcing the move in a press statement yesterday (May 16), the agency noted that Lucemyra (lofexidine hydrochloride) is meant to help adults who abruptly stop taking the addictive painkillers, and is only approved for treatment for up to two weeks.
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.
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