profishingrods.com
profishingrods.com November 15, 2018


FDA approves highly effective new opioid regardless of ongoing epidemic

07 November 2018, 11:29 | Randall Craig

The FDA just approved an opioid painkiller 10 times more powerful than fentanyl

FDA approves new opioid

The U.S. Food and Drug Administration approved a powerful new opioid medication on Friday, in spite of major concerns raised by health advocates that the drug's strength and design could prove harmful for patients and the public.

The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl. "The agency is taking new steps to more actively confront this crisis while also paying careful attention to the needs of patients and physicians managing pain". Each pill, placed under the tongue for quick absorption, would have the same impact as five milligrams of intravenous morphine. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market.




Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. For instance, it may not be administered at home, and can only be administered by a health care provider, which means that the drug will not be available at retail pharmacies. 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. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo. The single-strength tablet and single-unit packaging are created to mitigate the possibility of dosing errors, misuse and diversion. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis".

As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said.



Other News

Trending Now

Democrats Win Back Control of House, Republicans Will Hold Senate
In addition to the suburban Wake districts, Mecklenburg County Democrat Rachel Hunt is 71 votes ahead of state Rep. About 2 in 10 each choose the economy and immigration as their top issue , and just 1 in 10 say it's gun policy.

Republican Marsha Blackburn wins US Senate race in TN
And the former governor also energized Tennessee Democrats who had long struggled to gain traction in the state. Bredesen's moderate stances, he predicted, would give these voters an easy excuse not to vote for her.

US Lays Down Razor Wire On Southern Border
Asked about the cost of the operation, Manning said it had yet to be determined by the Pentagon's financial services. Trump has been very vocal about the caravan, calling it an "invasion" and saying it will be met by the military.

Top Storylines for Seattle Seahawks vs. Los Angeles Chargers
After a slow start, Russell Wilson is lighting up defenses like a Christmas tree, and no it is not too early to start celebrating. Another victory for the surging Chargers, holding off Wilson's late rally for a 25-17 win over the Seattle Seahawks on Sunday.

CNN slams ‘schizophrenic moment’ Fox’s Hannity joins Trump on stage
Hannity himself also tweeted Tuesday , "What I said in my tweet yesterday was 100% truthful". Trump told Hannity he had seen the beginning of his show.

New Breaking Bad film confirmed
Set to return are producers Mark Johnson and Melissa Bernstein who have worked with Gilligan both on Breaking Bad and Better Call Saul .

Idris Elba Named Sexiest Man Alive by People Magazine
Idris was also a popular choice for the honor previous year , but it was given to Blake Shelton . I got picked on a little bit. "Grew a moustache, had some muscles, bonkers".

Where To Vote Near Me in Today's 2018 Election
Voting begins at various times depending on the town or city, but most polls open at 7 or 8 a.m. For questions regarding polling places, always consult your County Elections Office .

Iran sanctions: "Maximum" economic pressure, Treasury's Mnuchin says
Unlike many other news organizations, we have not put up a paywall. "I don't want to lift oil prices ". Oil prices rallied above $85 per barrel in October on fears of a steep decline in Iranian exports.

Free Fries, Coffee & Beer: Election Day Deals In Minnesota
Potbelly Sandwich Shop: Customers can receive a free cookie with any purchase by showing their "I voted" sticker, Delish reports . California Tortilla: New Jersey and CT voters who say "I voted" can enjoy free chips and queso with any in-store purchase.