FDA Approves Painkiller Dsuvia Amid Criticism

Share
FDA Approves Painkiller Dsuvia Amid Criticism

The Food and Drug Administration approved a drug called Dsuvia Friday.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". 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.

"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.

"To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use", Gottlieb said. "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Dr. Gottlieb said. The opioid in question is a highly potent, and unsafe drug that has more risks than benefits in health-care. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.

But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.

For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. 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.

Share

Advertisement

Related Posts

Florida approves ballot measure restoring felons' voting rights
A number of major Jewish philanthropists contributed to the campaign, including George Soros, Seth Klarman and Stacy Schusterman. On Tuesday, the Sunshine State also voted to ban dog racing involving wagering by 2020.

Pakistani state broadcaster apologises for error during PM Khan's Beijing speech
Pakistan Television Corporation (PTV) had messed up the dateline of Khan's speech by spelling Beijing as "Begging". China while stating that it would extend necessary support to Pakistan, reportedly committed $6 billion funding.

Tallahassee Mayor Gillum, Republican former Rep. DeSantis cast votes
Florida's more than 13 million registered voters are choosing a new governor and voting on a pivotal U.S. Fox News projected DeSantis , a former congressman, would win with 99 percent of precincts reporting .

Spice Girls reunite, minus Victoria Beckham, Lifestyle News & Top Stories
Chris mentioned Heart on a number of occasions saying Emma was presenting her own breakfast show and that we are all one in radio. The Spice Girls - minus Victoria Beckham - announced the initial six United Kingdom stadium dates on Monday.

MI voters legalize recreational marijuana use
Recreational marijuana advocates were lighting up and passing joints in Detroit after a ballot proposal passed to legalize pot. Impose a 10-ounce limit for marijuana kept at residences and require amounts over 2.5 ounces be secured in locked containers.

Red Dead Redemption 2: How to Fix the Missing Camp Bug
If you have bought the Ultimate or Special Edition of Red Dead Redemption 2 then this will be available to you for a free of cost. You can ask one of the women of the gang for a dance, and somewhat clumsily sway with her, or offer a quick dip.

Moon Jae-in anxious about helipad if Kim Jong Un visits South
Vice Foreign Minister Choe Son Hui is expected to accompany Kim Yong Chol , who is likely to visit NY for talks with U.S. Secretary of State Mike Pompeo , the source said.

Ocasio-Cortez becomes youngest woman elected to Congress
Republican leaders have cited Kavanaugh's eventual confirmation as a catalyst for Republican enthusiasm in this year's elections. Democrats were also much angrier about the Senate's handling of Kavanaugh's confirmation than Republicans or independents.

European Union to offer Irish border compromise in Brexit talks
But the spokesman cautioned: "Don't be under any illusion, there remains a significant amount of work to do". He tweeted: "Such an outcome will have serious consequences for economy of Irish Republic".

Americans elect Muslim women to Congress for the first time
Tlaib has advocated for universal health care, a $15 national minimum wage, union protections, and tuition-free college education. When the new Congress convenes in January 2019, for the first time it will have at least one Muslim woman among its ranks.

© 2015 ExpressNewsline. All Rights reserved.