FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

FDA OKs first non-opioid treatment for opioid withdrawal

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 over-the-counter remedies for upset stomach or aches and pains. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder. Specifically, the studies will investigate the safety of Lucemyra in situations where use may last beyond the 14-day recommended treatment period, as well as what the effects may be on blood pressure after the treatment is discontinued. The drug should be available by the summer. Some patients experience mental side effects like anxiety and agitation, while others have physical ailments like vomiting and drug craving.

The Food and Drug Administration (FDA) approved the first nonopioid treatment on Wednesday to ease withdrawal symptoms while quitting opioids. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately be overcoming addiction. Treatment may continue for up to 14 days and should be discontinued gradually over 2-4 days. "And those who seek assistance may relapse due to continued withdrawal symptoms", the FDA said in a May 16 statement.

The drug Lucemyra reduces the severity of withdrawal symptoms but can not eliminate them altogether. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment. Announcing the move in a press statement yesterday (May 16), the agency noted that Lucemyra (lofexidine hydrochloride) is meant to help adults who abruptly stop taking the addictive painkillers, and is only approved for treatment for up to two weeks. Each of the symptoms were rated by the patients as either "none, mild, moderate and severe". More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age.

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The FDA granted Lucemyra the go-ahead after previous priority review and fast track designations, and it comes after an independent scientific panel voted 11-1 in favor of its approval.

The FDA is requiring 15 postmarketing studies, including both animal and human studies.

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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