Published: Fri, May 18, 2018
Medicine | By Earnest Bishop

FDA approves drug to help with opioid withdrawal symptoms

FDA approves drug to help with opioid withdrawal symptoms

We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use.

Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped.

Privately held US WorldMeds said it had not yet set a price for Lucemyra. Some patients experience mental side effects like anxiety and agitation, while others have physical ailments like vomiting and drug craving.

The US Food and Drug Administration today approved lofexidine hydrochloride (Lucemyra, US WorldMeds, Kentucky) for the mitigation of opioid withdrawal symptoms in adults.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help". The approved treatment period is up to 14 days. "And those who seek assistance may relapse due to continued withdrawal symptoms".

The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action.

Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

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To test the drug, researchers conducted a pair of random clinical trials. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms.

The most widely recognized symptoms from treatment with Lucemyra incorporate hypotension (low circulatory strain), bradycardia (moderate heart rate), drowsiness (lethargy), sedation and wooziness. Less common reactions could include fainting and abnormal heart rhythms.

The FDA is requiring 15 postmarketing examines, including both creature and human examinations. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age.

An independent FDA advisory committee supported approving Lucemyra in March.

Use of lofexidine should be part of a long-term treatment plan for patients stopping opioids when physically dependent, the FDA and US WorldMeds indicated.

US WorldMeds - a former Vogt Award victor in Louisville - "has been developing the data needed for FDA approval for over 10 years", he said, adding, "Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds".

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