FDA approves 1st nonopioid drug to ease withdrawal symptoms

FDA approves 1st nonopioid drug to ease withdrawal symptoms

FDA approves 1st nonopioid drug to ease withdrawal symptoms

The statement mentions that Lucemyra is not a treatment of opioid use disorder (OUD) but a part of its management. Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug created to fight those symptoms.

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

Lucemyra suppresses the neurochemical surge that leads to the sometimes agonizing symptoms of opioid withdrawal, such as pain, muscle twitching and stomach cramps.

For patients using opioids appropriately, withdrawal is usually managed by slow reduction in doses.

"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said. Before, people going through detox were given opioids which can be very addictive.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. It is essentially a selective alpha 2-adrenergic receptor agonist.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions.

Typical patients will receive three tablets taken orally four times a day at five- to six-hour intervals during the period of peak withdrawal symptoms. It is not approved as a treatment for opioid use disorder. These studies included a total of 866 adults who met the criteria for Diagnostic and Statistical Manual-IV criteria for opioid dependence and who were undergoing an abrupt opioid withdrawal process.

The most common side effects from treatment include hypotension, bradycardia, somnolence, sedation and dizziness, and was also associated with a few cases of syncope.

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds.

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. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA. The approval for making the drug is granted to US WorldMeds LLC.

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