The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY-based US WorldMeds. Plus, patients who got Lucemyra were more likely to complete the course of treatment, which can only last for up to 14 days. 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.
Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped. There were a few cases of fainting or syncope and an increased risk of heart arrhythmias. Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms.
The FDA still wants Lucemyra to conduct some safety studies to see the effects on children. It is essentially a selective alpha 2-adrenergic receptor agonist.
New medication targets symptoms experienced when reducing or stopping opioids due to physical dependence. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.
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The pill was approved to treat adults for up to two weeks for common withdrawal symptoms like vomiting, diarrhea, muscle pain and agitation. 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.
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 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. The drug has not been evaluated in people under age 17, the FDA said. An advisory committee this March had approved Lucemyra and had advised the FDA accordingly. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA.
The FDA conceded the endorsement of Lucemyra to US WorldMeds LLC.