Friday, 2 November 2018

F.D.A. Approves Powerful New Opioid Despite Warnings of Likely Abuse

F.D.A. Approves
WASHINGTON — The Food and Drug Administration on Friday approved a replacement sort of a particularly potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it might likely be abused.

The drug, Dsuvia, maybe a tablet sort of sufentanil, an artificial opioid that has been used intravenously and in epidurals since the 1980s.

It is 10 times stronger than fentanyl, a parent drug that's often utilized in hospitals but is additionally produced illegally in forms that have caused tens of thousands of overdose deaths in recent years.

Although the F.D.A. advisory committee charged with evaluating the new formulation ultimately recommended during a 10-3 vote last month that the agency approve it, the panel’s chairman, Dr. Raeford Brown, wrote a letter to top F.D.A. officials afterward expressing deep concern.

In the letter, which he wrote with leaders of the buyer advocacy group Public Citizen, Dr. Brown, an anesthesiology professor at the University of Kentucky, described Dsuvia,
made by AcelRx Pharmaceuticals, as “an extremely divertible drug,” adding, “I predict that we'll encounter diversion, abuse, and death within the first months of its availability on the market.”

After the ultimate approval on Friday, Dr. Scott Gottlieb, the F.D.A. commissioner, released a lengthy statement defending the agency’s decision.

He emphasized that Dsuvia is delivered through a “pre-filled, single-dose applicator,” and said that its only permitted use is going to be in hospitals, surgical centers, and other medically supervised settings.

It is ideally fitted to certain special circumstances, he said, particularly for soldiers wounded on the battlefield who won't have access to intravenous painkillers.

Dr. Gottlieb wrote that Dsuvia won't be dispensed to patients for home use or available at retail pharmacies which should only be administered by health care providers with the single-dose applicators. it'll likely hit the market early next year.

“These measures to limit the utilization of this product only within a supervised health care setting, and not for home use, are important steps to assist prevent misuse and abuse,” he wrote.

He also pointed to the agency’s new powers to need post-market studies evaluating the efficacy of opioid medications that the F.D.A. could be having second thoughts about and to think about abuse risk as an element in making regulatory decisions about drugs after, also as before, they’re on the market.

Last year, the F.D.A. asked the maker of Opana ER, another super-potent opioid, to require it off the market due to concerns about abuse.

Vince Angotti, the chief executive of AcelRx, said during a statement that the corporate would diligently follow a security program, referred to as a risk evaluation and mitigation strategy, that the F.D.A. had approved for Dsuvia, including monitoring distribution of the drug and auditing wholesalers’ data; evaluating whether hospitals and other health care providers are using the drug properly; and monitoring for any diversion or abuse.

The divisions over the new drug’s approval come after opioid overdose deaths surged to quite 40,000 last year, including quite 30,000 from fentanyl and other synthetic opioids.

States and therefore the federal governments have cracked down on the prescribing of opioids and lots of chronic pain patients have complained about being undertreated or losing access to opioids entirely.

Dr. Brown, who heads the advisory committee on analgesics and anesthetic drug products, wasn't present for the committee vote last month.

But within the letter he wrote afterward, he described trying to resuscitate doctors, medical students, and other health care providers — “some successfully” — who had overdosed on the IV sort of sufentanil at the center where he's employed “It is so potent that abusers of this intravenous formulation often die once they inject the primary dose,” he wrote.

Dr. Brown also questioned whether the F.D.A. would achieve enforcing regulations once dangerous drugs hit the market.

“It is my observation that when the F.D.A. approves an opioid compound,” he wrote, “There are not any safeguards on the population which will be exposed, the post-marketing analysis of prescribing behavior, or the continued analysis of the risks of the drug to the overall population.”

Critics of the approval include four Democratic senators — Edward Markey of Massachusetts, Richard Blumenthal of Connecticut, Claire McCaskill of Missouri and Joe Manchin of West Virginia.
In a letter to Dr. Gottlieb on Tuesday, they questioned why Dr. Brown’s committee went ahead and recommended approval on Oct. 12 without him present.

They also asked why a special F.D.A. advisory group, the Drug Safety, and Risk Management Advisory Committee had not been involved.

An F.D.A. spokeswoman said that while the difficulty wasn't brought formally ahead of the drug safety committee, “there were drug safety and risk experts on the committee whose expert input was taken very seriously throughout this process.”

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