FDA approves first non-opioid drug to treat opioid withdrawal symptoms



The Food and Drug Administration (FDA) on Wednesday approved a medication to lessen the side effects of opioid withdrawal in an effort to help mitigate what Commissioner Scott Gottlieb called "one of the biggest barriers" for those deciding to seek treatment. Developing safe and effective treatments for opioid use disorder remained a major priority for the agency, stated a press announcement released on May 16.

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. Late symptoms may involve nausea, vomiting, diarrhea and, dilated pupils.

According to the National Institutes of Health (NIH), these symptoms can cause pain and discomfort but are usually not life-threatening.

For each opioid withdrawal symptom, patients are asked to rate their symptom severity using four response options (none, mild, moderate and severe), with the SOWS-Gossop total score ranging from 0 to 30, where a higher score indicates a greater withdrawal symptom severity. "Withdrawal reduces the person's tolerance to the drug, so those who have just gone through withdrawal can overdose on a much smaller dose than they used to take", the NIH website stated. The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. SOWS-Gossop scores were lower for patients treated with Lucemyra compared to placebo, and more patients completed the treatment period of the studies in the Lucemyra group compared to placebo. And those who seek assistance may relapse due to continued withdrawal symptoms.

The safety and efficacy have not been established in children or adolescents 17 years of age and younger.

According to estimates, more than 115 people die each day in the USA after overdosing on opioids. On May 15, six states filed lawsuits against Purdue Pharma (the maker of prescription painkiller OxyContin) for misleading the public and fueling the on-going opioid crisis.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

The FDA granted the approval of Lucemyra to US WorldMeds LLC.

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