NEW FDA APPROVED PAINKILLER: WILL IT EVENTUALLY KILL MORE AMERICANS?

…Dsuvia & it's applicator

The current opioid epidemic killed a record 49,000 US users in 2017

The Food and Drug Administration (FDA) has just approved a powerful opioid for use only in health-care settings, (This means, it will not be available in retail drug stores.)  This also rejects the criticism from some of its advisers that the drug would inevitably become an illicit drug which would most likely cause more overdose deaths.  But drug history says, once a drug hits the market, it eventually becomes available by being diverted from the supply chain, from the black market, or it could become duplicated by illegal labs outside the US.

This opioid is 5 to 10 times more potent than pharmaceutical “fentanyl”.  It’s a tiny pill that is just three millimeters in diameter, and it would likely worsen the nation’s drug crisis.  This is according to critics and the head of the FDA’s advisory committee on painkillers.  The approved drug is a 30-microgram pill form of “sufentanil”, a powerful, 34-year-old opioid commonly used after surgery and in emergency rooms. Each pill is placed under the tongue for quick absorption, and it would have the same impact as five milligrams of intravenous morphine. Each would come in a plastic applicator that looks like a syringe.

FDA Commissioner, Scott Gottlieb, has 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.  This might allow the agency to turn down future applications for new opioid approvals.

One factor that weighed heavily in the approval decision is the military’s interest in the drug.  The military wants to use the pill as a battlefield painkiller that is less cumbersome than liquid analgesics. The Pentagon has spent millions of dollars helping to fund the drug’s research, public documents show.

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain,” Gottlieb wrote.

“We need to address the question that I believe underlies the criticism raised in advance of this approval,” Gottlieb wrote. “To what extent should we evaluate each opioid solely on its own merits, and to what extent should we also consider . . . the epidemic of opioid misuse and abuse that’s gripping our nation?”

The worst drug crisis in US history has since accelerated.  The agency’s critics and some public officials have clamored for a holistic approach to narcotic painkillers, instead of the FDA’s practice of evaluating each opioid application on its own.

Gottlieb has pledged the FDA would do more to balance efforts to curb the epidemic…which killed a record 49,000 users in 2017.  The drug was designed for needs of people who need strong pain relief.  

The manufacturer of the pill is a California company called AcelRx which will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.  An AcelRx spokeswoman said the company is not providing information on expected sales.  AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.

An FDA advisory committee recommended approval of the new drug in a 10-to-3 vote.  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.

Brown, plus four US Senators and the advocacy group Public Citizen have predicted Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Sidney Wolfe, founder of Public Citizen’s Health Research Group, said in a statement. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

Brown added he has personally attempted to resuscitate some health-care providers who abused sufentanil, “some, but not all were successful.”

“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said in his joint statement with Public Citizen

A 2016 survey conducted by the federal Substance Abuse and Mental Health Services (SAMHSA) shows narcotics are rarely stolen from doctors’ offices, clinics, hospitals or pharmacies. Fewer than 1% of people said they acquired opioids that way.

However, the rate of overdose deaths among health-care workers is relatively high, this is according to a recent study by the Centers for Disease Control and Prevention, with 876 individuals succumbing to prescription opioids between 2007 and 2012.

Hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal users over the past 15 years. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to the SAMHSA survey.

Pamela Palmer, an anesthesiologist, said she founded the company, AcelRx, to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.  She said caregivers can make these mistakes by mis-calculating the amount of clear liquid painkillers such as morphine to administer intravenously.

“The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” Palmer said in a statement.

Including the brand name and generic drugs, there are nearly 400 opioids on the market.

A spokesman for the Pharmaceutical Research and Manufacturers of America said the organization shares the “FDA’s commitment to reducing the risk of addiction and combating the opioid crisis while also ensuring new treatments reach patients in need.”

This is a statement that is all good and well, and it sounds good at the out-set.  But where was this thinking as millions of doses of prescription painkillers were being diverted from the supply chain?

Many people in an industry that already has 400 opioids on the market feel that this will just be one more very powerful drug that has the ability to kill a human even faster than what’s already available.

Isn’t enough, enough?

Copyright G.Ater  2018