First Non-Opioid Treatment for Opioid Withdrawal in Adults Gains FDA Approval

The FDA approved lofexidine hydrochloride (Lucemyra) for the mitigation of opioid withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, aged 18 and older.

The FDA approved lofexidine hydrochloride (Lucemyra) for the mitigation of opioid withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, aged 18 and older. While lofexidine hydrochloride may lessen the severity of withdrawal symptoms, it may not completely prevent them, and is only approved for treatment for up to 14 days, according to a press release issued by the FDA. Lofexidine hydrochloride is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing the condition.

Physical dependence to opioids is an expected physiological response to opioid use. Withdrawal symptoms, such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving, can occur after stopping or reducing the use of opioids, in an individual with physical dependence. Symptoms of opioid withdrawal occur in patients who have been using opioids appropriately as prescribed, and in patients with OUD.

In patients using opioid analgesics appropriately, as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is intended to avoid or lessen the effects of withdrawal, while allowing the body to adapt to not having the opioid. In patients with OUD, withdrawal is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to maintenance therapy with FDA-approved medication-assisted treatment drugs, such as methadone, buprenorphine or naltrexone; or by various medications aimed at specific symptoms, such as OTC remedies for upset stomach or aches and pains. Other treatments may also be prescribed by a patient’s health care provider.

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