The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days.
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.
Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction.
Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy.
The federal government and Congress are grappling with how to stem the tide of the opioid epidemic, which has shown no signs of slowing down and is contributing to an estimated 115 American deaths per day. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. Fear of withdrawal discourages some people from quitting.
The FDA's decision was supported by data gathered from two clinical studies that involved 866, clinically opioid-dependent adults, following abrupt discontinuation of use.
Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine and its actions are believed to play a role in the symptoms of withdrawal.
In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction".
The FDA is requiring 15 postmarketing studies, including both animal and human studies. Animal safety studies will look at the drug's longer-term use and its use in children, the agency said. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.