Published: Fri, May 18, 2018
Health Care | By Gwendolyn Kim

FDA Approves First Non-Opioid Drug to Treat Withdrawal Sx

FDA Approves First Non-Opioid Drug to Treat Withdrawal Sx

Singapore- The U.S. Food and Drug Administration approved privately held US WorldMeds LLC's Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal. Although Lucemyra may lessen the severity of withdrawal symptoms, it may not entirely prevent them and is only approved for treatment for up to two weeks, the agency stated.

The drug Lofexidine, marketed as Lucemyra, will be the first non-opioid treatment for managing withdrawal symptoms.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time. Before, people going through detox were given opioids which can be very addictive. These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing.

Beloved Actress Margot Kidder Famous for Playing Lois Lane Dead at 69
She was arrested at the White House in 2011 during a protest against the construction of an oil pipeline from Alberta to Texas. In 2015 she won an Emmy award for Outstanding Performer in Children's Programming for her performance on an episode of R.L.

Can another redesign bring Snapchat back from the brink?
Just a few months after the last refresh, the Snapchat app is once again getting a facelift. A redesign of the app followed, although it has been immensely polarizing.

DJI And Microsoft Partner To Bring Advanced Drone Technology To The Enterprise
Azure Bot Service uses the Microsoft Bot Framework , which reported more than 130,000 users one year ago . It is expected that Microsoft might announce its plans for the upcoming Surface device at Build 2018.

Sublocade is approved to treat opioid abuse disorder, but it also contains opioids itelf. Results showed that SOWS-Gossop scores were lower in patients who are treated with Lucemyra compared to placebo. Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids.

"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 reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.

The agency is now requiring 15 postmarketing studies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Like this: