FDA Commissioner Says FDA Will Listen to Chronic Pain Patients About Opioids

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

The non-opioid tablets can be used for up to two weeks.

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine.

For those addicted to opioids, quitting cold turkey can be a harrowing experience. The drugs are notoriously addictive, with withdrawal symptoms including extreme nausea, vomiting, and anxiety. These symptoms include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.

Withdrawal is typically managed with the substitution of another opioid, like buprenorphine or methadone, which is then gradually reduced. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction.

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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 is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine. For approval the manufacturers submitted results of two randomized, double-blind, placebo-controlled clinical trials. "The lofexidine data demonstrate that, compared with placebo, study participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were significantly more likely to complete opioid withdrawal treatment".

The agency is now requiring 15 postmarketing studies.

The newly approved drug isn't a medication for opioid addiction, but is seen as a step toward helping some people begin medication-assisted treatment, seen as the gold standard of addiction care. It is not approved as a treatment for opioid use disorder. Concentrates in pediatric patients will incorporate investigations of babies with neonatal opioid withdrawal and investigations of various age gatherings of youngsters who have opioid withdrawal identified with ceasing therapeutically recommended opioid drugs. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. There were safety signals, however, with some of the most common side effects from treatment being low blood pressure and slow heart rate. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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