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Drug Withdrawal Symptoms Eased by FDA-Approved Nonopioid Drug

18 May 2018, 03:57 | Winifred Adams

The FDA approved a nonopioid drug to assist with opioid withdrawal symptoms as a tool to fight the U.S. opioid crisis

The FDA approved a nonopioid drug to assist with opioid withdrawal symptoms as a tool to fight the U.S. opioid crisis

Rather, the medication may help to alleviate withdrawal symptoms among those who have developed a physical dependence to opioids and are stopping or reducing their dosage.

In a statement, FDA Commissioner Scott Gottlieb said the approval was a positive development in the agency's continued effort to help people overcome opioid addiction. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age. This was a patient-reported outcome instrument that could help patients report their symptoms after intake of the drug.

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 fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help.

Because Lucemyra will be available without the restrictions surrounding drugs like buprenorphine or methadone, patients potentially will be able to get it from their family doctor, Pirner told Insider. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores were found to be lower for patients treated with Lucemyra, and more patients finished the treatment in the Lucemyra group versus the placebo group.

Opioid withdrawal incorporates indications for example - uneasiness, unsettling, rest issues, muscle hurts, runny nose, sweating, sickness, spewing, loose bowels and medication wanting - that happens in the wake of ceasing or lessening the utilization of opioids in anybody with physical reliance on opioids.

For each withdrawal symptom, patients were asked to rate the severity using 4 response options (none, mild, moderate and severe) with the SOWS-Gossop total score ranging from 0-30-a higher score indicated a greater withdrawal symptom severity.

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Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients.

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".

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".

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.



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