"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.
We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs.
US WorldMeds anticipates that Lucemyra's use will go beyond those who are full-fledged addicts. 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.
The US Food and Drug Administration (FDA) approved lofexidine hydrochloride (Lucemyra) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, announced US WorldMeds.
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"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help". More patients in the Lucemyra group completed the treatment period of the studies vs patients in the placebo group. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said.
The most widely recognized symptoms from treatment with Lucemyra incorporate hypotension (low circulatory strain), bradycardia (moderate heart rate), drowsiness (lethargy), sedation and wooziness. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment. The drug can also elevate the risk of abnormal heart rhythms.
The safety and efficacy of Lucemyra have not been established in pediatric patients 17 years of age. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. FDA has requested 15 post-marketing studies, in both animals and humans, to support longer-term use and use in children. 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.
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". The approval for making the drug is granted to US WorldMeds LLC.