FDA clears new tool in fight against opioid epidemic
09:31, May 18, 2018
Copyright 2015 All rights reserved. This material can't be published, transferred, copied or redistributed.
Drug withdrawal symptoms can now be eased by a new nonopioid treatment approved by Federal regulators on Wednesday, the first to ease withdrawal from quitting addictive opioids. 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.
Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.
US WorldMeds anticipates that Lucemyra's use will go beyond those who are full-fledged addicts. At present the new drug has been granted Priority Review and Fast Track approval. 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 non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids.
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". SOWS-Gossop scores were lower for patients treated with Lucemyra compared to placebo, and more patients completed the treatment period of the studies in the Lucemyra group compared to placebo. Reported adverse side effects include low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms.
"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 safety and efficacy of Lucemyra have not been established in children or adolescents under age 17. Additionally, an independent FDA advisory committee supported the approval at a meeting in March. Although it is not an addiction medicine, it can be part of a longer-term treatment plan, according to the FDA. 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. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.
Democrats accused Rauner, who faces a re-election challenge, of using the death penalty as a political weapon. The governor additionally sought so as to add a ban on bump shares to the invoice, he stated on social media.
Donald Trump is crowing about keeping his promise to scuttle the deal, but this is one promise that should never have been made. During the last round of sanctions prior to the nuclear deal , Iran's oil supplies fell by around one million barrels per day.
The PC version of the game will only be available through Blizzard's Battle.net client, according to reports by Gaming Intel . Then again, we will simply have to wait and see what's in store for us when Black Ops 4 is more fully revealed.
Howard described watching the film at Cannes as a "blast", calling it "a great jumping off place for a movie like ours". If Rogue One didn't hammer it in hard enough, Solo reminds us once again that this galaxy is constantly at war.
According to the officials' latest announcement, the political coalition of Shia Muslim cleric Muqtada al-Sadr has an early lead. Official results are expected to be announced by the end of Monday, 48 hours after polling stations around the country closed.
He also regretted not being able to programme Alfonso Cuaron's film "Roma", about the director's growing-up years in Mexico. Sonam Kapoor-Ahuja will be at the French Riviera as a newlywed and make heads turn on May 14 and 15.
National security adviser John Bolton with President Trump during an April cabinet meeting at the White House. The sanctions will target critical sectors of Iran's economy, including petrochemicals, energy and finance.
Vodafone chief Vittorio Colao to step down
He has been an exemplary leader and strategic visionary who has overseen a dramatic transformation of Vodafone . The news came as Vodafone announced its results for the year ended March 31, 2018.
Israel celebrates as US Embassy prepares to open in Jerusalem
The Israelis also fired tear gas at people inside the tented encampments that have sprung up along the border, witnesses said. Sullivan is leading the US delegation in the absence of Trump, Vice President Mike Pence and Secretary of State Mike Pompeo.
Khloe shows off baby True
In the Snap, she shared, "Today is the first day I've been allowed to work out with my trainer and I'm super excited". Another added, "I've been waiting on seeing her, every day I look to see if you've posted".
Walmart buys 77% stake in India's Flipkart for US$16 bln
Walmart entered India in 2009 through a joint venture with Bharti Enterprises, and took full control of that business in 2013. This deal should catch the eye of a number of large, foreign strategic investors who have been eyeing India for a long time .
Microsoft Kinect is back and this time it's all about AI
Furthermore, this is actually Microsoft's second crack at trying to make the Kinect into a business-focused product. On Android, the Redmond-based software major is taking advantage of Microsoft Launcher app to bring the feature .