Friday, 16 November, 2018

Ultra-Powerful Opioid Approved by FDA

FDA approves new opioid FDA approves new opioid
Delores Daniels | 07 November, 2018, 22:29

The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine". The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. "The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid", a statement from the public advocacy group Public Citizen said in response to the approval.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants.

Harvick Earns Shot at NASCAR Title With Victory in Texas
Of those only Logano was a factor as he led 54 laps. "That was really the only shot we had to beat him, to be honest with you". Also collecting stage points were Aric Almirola , Erik Jones , Kurt Busch , Daniel Suarez and Chase Elliott.

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it. 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.

The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.

Trump to reporter: 'You are a bad person'
He then berated Acosta for the way he questioned White House press secretary Sarah Huckabee Sanders in briefings. You and I disagree on this, ' Trump said. "You shouldn't treat people that way".

He also called the drug "a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield". Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg.

South Korea and U.S. resume military drills ahead of nuclear talks
Pompeo says President Donald Trump has made it clear to the North Koreans - "no economic relief until we have achieved our ultimate objective ".

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