The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
08 November, 2018, 08:37
A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.
The drug is five to 10 times more potent than pharmaceutical fentanyl. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use.
The U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision.
In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders.
In approving the drug, the agency skirted its normal vetting process, these critics say.
Xi to trumpet China's 'open' markets at trade forum The China International Import Expo (CIIE) is a "trail-blazing" move in the history of international trade development. Organisers of the expo say more than 3,000 foreign companies from 130 countries, including the USA , are present.
Utah mayor killed in Afghanistan serving with the National Guard It ended with an Afghan commando dead, although Rahimi declined to comment on whether this commando was a suspect in the killing. When he was ordered to deploy to Afghanistan in January, he announced that he would take a one year leave of absence as mayor.
The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record previous year with 72,000 deaths - about 200 per day.
Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market.
The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.
The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
Mitch Moreland was also a finalist for Gold Glove at first base but was beaten out by Oakland's Matt Olson . Houston pitcher Dallas Keuchel and Los Angeles Angels shortstop Andrelton Simmons also won in the AL.
Manuel Pellegrini got the performance he demanded from Felipe Anderson after West Ham's record buy sank Burnley . The academy product finished the game with six completed dribbles, more than any other player on the pitch.
Boeing said the "angle of attack" sensor, which identifies if a plane is about to stall, was faulty on the doomed flight. If pilots aren't careful, they can cause severe nose-down trim settings that make it impossible to level a plane.
Beckham captioned a picture of Mel B , Mel C, Emma Bunton and Geri Horner (née Halliwell). "It's just the four of us". Earlier on Monday, Bunton said on her Heart Radio breakfast show: "I'm just so excited, I want it out there".
Apple has also been trying to diversify its revenues away from device sales by offering additional services to its customers. For the firm's full 2018 financial year, profits increased 23% to $59.5bn, as revenue rose 16% to $265.5bn.
They also say Manchester United boss Jose Mourinho isn't bothered if his team concede goals as long as they win. The Champions League match between Liverpool and Red Star Belgrade will be broadcast live on TNT.
Sterling did in the 67th minute when he latched onto Aguero's perfectly-weighted pass to score his second goal of the afternoon. Pedro added the third goal from a left-wing cross by another Spaniard, Marcos Alonso, in the 70th.
May said on MUTV's Matchday Review programme: " I think Ander could have played himself into the team there ". Once again it was the United midfield which got carved open piling pressure on a shaky looking back line.
Encouragingly, Inter has been solid defensively in recent weeks, keeping a total of seven clean sheets in their last 19 matches. As for Barcelona , they can all but book their place in the round of sixteen with a victory against Inter on Tuesday evening.
Early voting season ended Saturday in West Virginia, with Northern Panhandle counties posting strong turnout numbers. Keep in mind, if there's a large turnout, voters might be required to wait before casting their ballots.
Speaking to WWE cameras after Crown Jewel , Michaels offered a subtle hint that he could be done in the ring after Saudi Arabia. Instead, the Beast will battle AJ Styles in a champion vs champion bout at Survivor Series later this month.
The iPad Pro will be faster than most portable computers
The graphics chip also pumps out around 2x more power, all without compromising the 10-hour battery life every iPad has gotten. Taking place in Brooklyn, New York, the company showcased latest MacBook Air , Mac mini , and new iPad Pros .
Amazon reportedly planning to split HQ2 between two cities
If it does turn out to be Crystal City and New York City, we hope Amazon has a plan for how to deal with all the traffic. The process certainly hasn't been rushed, as it took Amazon until January of 2018 to release their 20 city shortlist .
Andrew Lincoln to star in 3 'Walking Dead' movies
Now, we see our survivors a year and a half after the end of the war, rebuilding civilization under Rick's steadfast leadership. A viewer said: "Gotta give a shoutout to Andrew Lincoln for beautifully portraying Rick Grimes for over 8 years".
Amazon offers free shipping for everyone through the holidays
Target last month raised the stakes for the all-important holiday shopping rush, offering US customers free two-day shipping. Amazon is hoping increase sales after the company's revenue projection for the rest of the year fell below some estimates.
USA says it stands with Iranians as sanctions hit Tehran
Turkey is among eight nations granted temporary waivers from sanctions the US reimposed Monday on Iran's oil sector. Rouhani said in a statement . "We will proudly break the sanctions", he said at a meeting of economic officials.
Diablo Immortal will be one hell of blast on iPhone and iPad
Last night Blizzard announced Diablo Immortal , a mobile game set in between the second and third games in the action-RPG series. We'll have more on Diablo Immortal as we go hands-on with the game at BlizzCon and speak to Blizzard about this new direction.
India announce final 12 for first T20I against Windies
Star Sports 1, Star Sports Tamil and Star Sports Hindi will provide live television coverage of the match in India . The Eden centre strip promises to be full of runs, and batsmen from both sides will look to make merry.