The Middletown Press (Middletown, CT)
FDA approves medicine to manage opioid withdrawal
The U.S. Food and Drug Administration has approved the first non-opioid treatment for management of opioid withdrawal in adults, which the agency said could help lessen one of the barriers to those looking to stop using the drugs.
The FDA announced Wednesday that it had approved Lucemyra (lofexidine hydrochloride) “for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.” However, the release added that the medication might not totally remove withdrawal symptoms and is only approved for treatment for up to 14 days.
“Lucemyra is not a treatment for opioid use disorder but can be used as part of a broader, long-term treatment plan for managing OUD,” the release read.
Opioid abuse is an escalating health crisis, both nationwide and in Connecticut. Last year, there were 1,038 accidental drug intoxication deaths in Connecticut — the first time the number of such deaths has topped a thousand in at least five years. A large number of those deaths involved opioids in some capacity.
“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Dr. Scott Gottlieb in a news release. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.”
Opioid withdrawal includes symptoms — such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving — that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.
In patients using opioids appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication. For those with opioid use disorder, the FDA states, “withdrawal is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to maintenance therapy with FDAapproved medication-assisted treatment drugs such as methadone, buprenorphine or naltrexone; or by various medications aimed at specific symptoms, such as over-the-counter remedies for upset stomach or aches and pains. Other treatments may also be prescribed by a patient’s health care provider.”