The US Food and Drug Administration (FDA) approved lofexidine hydrochloride (Lucemyra) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, announced US WorldMeds.
The oral, non-opioid, selective alpha 2-adrenergic receptor agonist reduces the release of norepinephrine. This committee received public input from patients who use opioids to manage their chronic pain. The agency also pointed out that Lucemyra is not meant to treat opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction", said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine. "We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms". Fear of withdrawal discourages some people from quitting. Additionally, the therapy has not been approved to treat opioid use disorder, but is meant to be used as part of a long-term treatment plan for the condition. "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 safety and efficacy have not been established in children or adolescents 17 years of age and younger.More news: Hilary Duff's Boyfriend Accused of Punching Neighbor in Smoking Dispute
Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms.
The FDA said that Lucemyra is only approved for up to 14 days.
While there are now some other approved drugs that mitigate withdrawal symptoms, many are themselves opioids, such as buprenorphine, or target specific symptoms alongside underlying opioid dependency. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.
In 2016, opioid-related overdoses in the USA led to more than 42,000 deaths-a toll that exceeded the number of people killed in vehicle crashes.More news: 'Horrific' school bus crash in New Jersey
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.
Human studies are needed to find out how safe lofexidine is if it's used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped.
The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March.More news: Fortnite Solo Showdown: What Is The New Limited Time Mode?