First non-opioid treatment for withdrawals gets FDA approval

First non-opioid treatment for withdrawals gets FDA approval

First non-opioid treatment for withdrawals gets FDA approval

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal. Treatment with Lucemyra may lessen the severity of opioid withdrawal symptoms but it may not completely prevent them. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA.

The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from opioids.

The non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids. Extra creature security studies will be required to help longer-term utilize, (for example, amid a progressive opioid decrease in torment patients stopping opioid analgesics) and use in youngsters. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said.

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So people who have been afraid to seek help "might be willing to now go talk to their health care provider", he said. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo.

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. It is approved for treatment for only up to 14 days. Lucemyra was also associated with a few cases of syncope (fainting). Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms. When treatment is stopped, patients can experience a marked increase in blood pressure.

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In 2016, opioid-related overdoses in the US led to more than 42,000 deaths-a toll that exceeded the number of people killed in auto crashes.

The FDA is requiring 15 post-marketing studies - or studies that happen after a drug is approved.

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.

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The approval of WorldMed's Lucemyra was expedited in an effort to combat the opioid epidemic.

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