Health issues associated with withdrawal symptoms during therapeutic practices involving addictive opioids have long been a challenge for medical practitioners. After illegal drugs, prescription painkillers are the primary cause of opioid-related health issues and death.
One of the potential solutions mooted by researchers was the development of formulations that prevent withdrawal symptoms from manifesting. While an array of medicines are available for the treatment of opioid addiction, produced by pharma majors like Pfizer (PFE) and Merck (MRK), no headway was made hitherto in developing an effective drug to curb withdrawal symptoms in people quitting addiction.
In a major breakthrough, the FDA has approved the first pharmaceutical formulation that reduces withdrawal symptoms and makes quitting addictive opioids easier. The drug, Lucemyra, was found to be effective in alleviating the common withdrawal symptoms such as muscle pain, agitation vomiting and diarrhea. Lucemyra does not fall under the addiction medicine category, and is indicated for treatment of adults for up to two weeks in longer-term treatment plans.
The clinical trials that made Lucemyra eligible for FDA approval showed people who took the drug experienced withdrawal symptoms of lower intensity while discontinuing opioids, compared to those who were given placebo. It comes as a major relief to opioid-addicted people who refuse to undergo treatment due to the fear of withdrawal symptoms.
FDA approved the first drug that reduces withdrawal symptoms and makes quitting addictive opioids easier
Considering the severity of opioid addiction, the FDA had expedited the approval process. Kentucky-based US WorldMeds, the manufacture of Lucemyra, is required to conduct further clinical trials in young people and opioid-addicted mothers of newborns for long-term treatment. The privately held company is yet to price the new drug.
“We are humbled to bring to market the first and only non-opioid treatment for the mitigation of withdrawal symptoms – and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment,” said US WorldMeds CEO Breckinridge Jones.
Meanwhile, the pill has its own side effects such as dizziness, low blood pressure, lightheadedness, and sleepiness.
It is a fact that whenever researchers come up with treatments for unaddressed health issues it brings cheer to those affected. But, Lucemyra is not just another drug, and it raises a serious question. While offering relief to patients suffering from overdependence on medicines, will formulations like Lucemyra add to the problem itself in the long run?