The Food and Drug Administration (FDA) has approved the first non-opioid therapy for the management of opioid withdrawal symptoms.
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".
Recommended dosing for lofexidine is three 0.18 mg tablets taken orally four times daily, when patients are experiencing peak withdrawal symptoms (generally 5 to 7 days following last use of opioids, the company said in a news release). Rather, the medication may help to alleviate withdrawal symptoms among those who have developed a physical dependence to opioids and are stopping or reducing their dosage. Clinical investigations will be required to assess the wellbeing of Lucemyra in clinical circumstances where utilize could be relied upon to surpass the most extreme 14-day treatment period for which the item is as of now affirmed, for example, steady opioid decrease; to accumulate extra security information on the impacts of lofexidine on the liver; and to additionally describe the consequences for circulatory strain after lofexidine is halted.
Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.
SOWS-Gossop scores were lower for patients treated with Lucemyra versus placebo and more patients in the Lucemyra group completed the treatment period.
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The safety and efficacy have not been established in children or adolescents 17 years of age and younger. This hormone is believed to play a role in symptoms of opioid withdrawal, the FDA said.
The drug, which will be available in pharmacies across the country in August, was approved 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, according to US WorldMeds. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. Lucemyra was also associated with a few cases of syncope (fainting). When Lucemyra is stopped, patients can experience a marked increase in blood pressure.
The FDA is requiring 15 postmarketing studies, including both animal and human studies.
An independent FDA advisory committee supported approving Lucemyra in March. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.
The FDA conceded the endorsement of Lucemyra to US WorldMeds LLC.