The FDA approved the first non-opioid treatment for opioid withdrawal symptom management in adults. It is essentially a selective alpha 2-adrenergic receptor agonist.
The medicine is only approved to treat adults with withdrawal symptoms for up to 14 days.
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".
Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.
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.
US WorldMeds - a former Vogt Award victor in Louisville - "has been developing the data needed for FDA approval for over 10 years", he said, adding, "Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds". Adverse side effects included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth, said the release. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. 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. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver. "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 safety and efficacy have not been established in children or adolescents 17 years of age and younger.
An independent FDA advisory committee supported approving Lucemyra in March. The approval for making the drug is granted to US WorldMeds LLC.