Posted from: Monday, June 04, 2018 - 10:58 AM - Present

First Non-Opioid Treatment for Opioid Withdrawal Approved

May 16, 2018 – The U.S. FDA has approved Lucemyra™ (lofexidine hydrochloride), manufactured by US World Meds. The drug is indicated to mitigate withdrawal symptoms and facilitate abrupt discontinuation of opioids in adults. It is the first FDA-approved non-opioid treatment for opioid withdrawal.

Lucemyra is not intended to treat opioid use disorder (OUD), and does not prevent withdrawal symptoms. It can however lessen the severity of symptoms and be used as part of a long-term treatment plan for individuals with OUD. Recommended dosing is three 0.18mg tablets taken by mouth four times per day every five to six hours, for no more than 14 days. To prevent worsening of withdrawal symptoms, the dosage must be gradually reduced over a period of two to four days under a physician’s guidance before Lucemyra is discontinued.

In clinical trials, patients who received Lucemyra experienced less severe withdrawal symptoms when compared to patients who received a placebo. They were also more likely to complete a seven-day course of treatment for opioid discontinuation.

Symptoms of opioid withdrawal include anxiety, difficulty sleeping, muscle aches, nausea, sweating, diarrhea, and drug cravings. For patients with OUD, withdrawal is usually managed by substituting an opioid medication and then gradually reducing the dose until the patient can be transitioned to maintenance therapy.

US World Meds plans to launch Lucemyra by August of 2018. Pricing plans have not yet been announced.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, December 14, 2018 - 10:25 PM.