The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday.
The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from opioids. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately be overcoming addiction.
Lofexidine may ease withdrawal symptoms but may not completely prevent them.
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.
For each withdrawal symptom, patients were asked to rate the severity using 4 response options (none, mild, moderate and severe) with the SOWS-Gossop total score ranging from 0-30-a higher score indicated a greater withdrawal symptom severity.
Lucemyra, an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, was reviewed by the FDA under a priority review. And those who seek assistance may relapse due to continued withdrawal symptoms. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. Common side effects include a slow heart rate, low blood pressure, and sleepiness.
US WorldMeds anticipates it can have its opioid withdrawal medication available to help patients by August. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age. The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. Patients can experience any combination of these symptoms after ceasing opioid use. Participants treated with Lucemyra experienced less withdrawal symptoms when compared to participants who took the placebo instead. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. They include both animal and human studies.
The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.
As a major aspect of the U.S. Bureau of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA stays focused on tending to the national emergency of opioid compulsion on all fronts, with a critical spotlight on diminishing presentation to opioids and averting new enslavement; supporting the treatment of those with opioid utilize scatter; cultivating the advancement of novel torment treatment treatments and opioids more impervious to manhandle and abuse; and making a move against the individuals who add to the unlawful importation and offer of opioid items. 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.
Mount Olive police say westbound traffic is being diverted off Route 80 at exit 26 and to expect heavy delays along Route 46. Darren Tynan told The Record that multiple people were taken to a hospital after the accident about 50 miles west of NY .
As per reports, BJP leaders are seeking out the Governor to grant them a week's time to prove their majority in the house. He argued that the matter should not have been heard at this hour and it was "absolutely wrong" to do so.
Several banks have in recent days raised their oil price forecasts, citing tighter supplies and strong demand. Oil markets reacted bullishly, with worldwide benchmark Brent crude rising about 8 percent to $71 a barrel.
It also means you can immediately fix connectivity problems, and won't have to learn the hard way that your devices need to move. This approach is helpful if you're trying to troubleshoot a specific area in your home or office, but not a particular device.
Despite its innovative brand, it has taken a long time for the bank to support Apple's contactless mobile payments offering. And when you sign an NDA with Apple it's not untypical for it to stipulate that you don't talk about said NDA.
After posting strong gains against the U.S. dollar in 2017, the rupee has fallen sharply against the greenback this year. The domestic unit opened strong by 10 paise at 67.70 at the interbank forex market today.
In Frosty's place, they plan to install "Leaky", which was the source of a large overboard ammonia leak about five years ago. Since they operate using highly toxic ammonia, the spacewalkers must take utmost care not to get any on their suits.
An early morning tragedy involving a pit bull attack has left a 75-year old woman dead and another woman in custody. They say the owner took off shortly after his pit bulls attacked another dog at Mission Dolores Park on Sunday.
Sharing the poster on his Twitter account, Irrfan Khan wrote, "Beginnings have the innocence that experience can't buy". The actor took to his handle to wish his " Karwaan " co-stars Dulquer Salmaan and Mithila Palkar for joining the film.
Housing Starts Drop 3.7% in April
The April decline was also driven by weakness in multifamily, which experienced a 13% drop in starts relative to March. The Trump administration in April previous year imposed anti-subsidy duties on imports of Canadian softwood lumber.
Bumble Bee CEO indicted for tuna price fixing
Department of Justice alleged Tuesday that Lischewski conspired with rival seafood companies to artificially inflate tuna prices. Bumble Bee, based in San Diego, pleaded guilty previous year to a criminal charge of conspiring to fix tuna prices.
JC Penney Q1 Comp Sales Flat
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Mac Miller Arrested for DUI, Hit and Run
A law-enforcement source told the site, "He was the most polite and nice intoxicated person we've ever seen". They promptly arrested him, and took him to jail, where he had a bail set at $15K.
Acacia Communications, Inc. (ACIA) held by 21 SEC 13F Filers
The highest price ACIA stock touched in the last 12 month was $50.1 and the lowest price it hit in the same period was $24.72. The firm has a market cap of $1.25 billion, a PE ratio of 26.47, a price-to-earnings-growth ratio of 60.39 and a beta of 1.11.
Analysts Ratings on: Enbridge Energy Management LLC (EEQ)
Investors look at the Volatility 12m to determine if a company has a low volatility percentage or not over the course of a year. We see here that Spectra Energy Partners, LP ( NYSE : SEP ) is -1.09% away from the 20-Day Simple Moving Average.
SA's blood pressure rate is rising
In addition, women also showed a 17 percent lower risk of major coronary heart disease or stroke, and men a 21 percent lower risk. He was on dialysis but that didn't help. "Feeling anxious or stressed when you visit your GP can also raise your blood pressure".
SA still at 72 in world football rankings
After a busy season last April, Harambee Stars moved two places up to position 111 in the global stage. Nigeria ranked behind Tunisia, Senegal, Congo DR, Morocco and Egypt, respectively.