FDA approves first non-opioid treatment for opioid withdrawal

FDA approves first non-opioid treatment for opioid withdrawal

In a May 16 announcement, the FDA stressed that Lucemyra isn't a treatment for opioid use disorder, but rather a potential tool for managing the disorder long-term.

Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns.

Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.

Patients' fear of experiencing withdrawal often hinders them from seeking treatment, and those who do seek help may relapse due to ongoing symptoms, Dr. Gottlieb added.

Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal.

The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY-based US WorldMeds.

These are seen in individuals who have physical dependence on opioids and also occurs if the dose is reduced.

The NIH says these symptoms aren't directly life-threatening, but they can drive the patient back to opioid use - often overdosing after experiencing withdrawal. It is not approved as a treatment for opioid use disorder.

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Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use. 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. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms.

Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth. Lucemyra was additionally connected with a couple of instances of syncope (blacking out). Lucemyra effect the heart's electrical activity, which can increase the risk of abnormal heart rhythms. At the point when Lucemyra is ceased, patients can encounter a stamped increment in the pulse.

The safety and efficacy of Lucemyra have not been established in children or adolescents under age 17.

In 2016, opioid-related overdoses in the US led to more than 42,000 deaths-a toll that exceeded the number of people killed in auto crashes.

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

The FDA said that Lucemyra is only approved for up to 14 days.

Patients with chronic pain can attend the FDA's "Patient-Focused Drug Development for Chronic Pain" meeting on July 9 from 10 a.m.to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online. Notably, the application for Lucemyra received Priority Review and Fast Track designations.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed.

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