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The Food and Drug Administration is about to approve a new form of powerful opioid for use in hospitals and emergency rooms, despite opposition from the committee leader who reviewed the drug.
On November 3rd, the FDA should decide whether it will allow a California company to produce a 30 microgram pill of sufentanil, a powerful painkiller commonly used after surgery.
An advisory committee of the FDA recommended the approval of the drug at a vote of 10 votes to 3 on October 12. The FDA usually follows the guidelines of these committees, made up of experts from various drugs and medical devices.
But in this case, the chairman of the committee, who missed the meeting because of a medical conference held in San Francisco that day, publicly urged the agency to reject the drug application because of the epidemic. overdoses of opioids in the United States. .
Raeford Brown, professor of anesthesiology and pediatrics at the University of Kentucky, who chairs the FDA's Anesthetics and Analgesics Advisory Committee, commented in a letter to FDA Commissioner Scott Gottlieb , and other leaders. He also made public his opposition, a rare step for a chair of the FDA advisory board.
Brown said that another powerful painkiller is not needed in medical centers. The drug is five to ten times more potent than pharmaceutical fentanyl. The tiny pill – just three millimeters in diameter – is virtually safe to be directed to the street, he said. Brown also said that the safety and effectiveness of this new drug have not yet been fully proven.
Senator Edward J. Markey (D-Mass.) And public advocacy group Public Citizen, who co-signed Brown's letter to Gottlieb, also oppose FDA's approval of the drug, which AcelRx would commercialize. under the name of Dsuvia.
"This is a drug that is being licensed at a time when we are trying to control the misuse and abuse of opioids in the United States," Brown said in an interview. "We still have [to] to be effective in preventing the diversion of these opioids and we are trying very hard. "
More than 49,000 people, a record number, have died from opioid overdoses in 2017, according to preliminary data released by the Centers for Disease Control and Prevention. The illegal street fentanyl, heroin and prescription narcotics are the cause of most of these deaths.
In July, Gottlieb issued a statement in which he promised the FDA would balance its efforts to stem the drug crisis with the needs of patients in pain.
"The FDA remains focused on finding the right balance between reducing the rate of new addictions by reducing opioid exposure and streamlining prescription, while allowing appropriate access to patients who have a legitimate medical need for these drugs." , did he declare.
Hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal users over the past 15 years, during what has become the worst drug crisis in history the United States. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to a survey conducted in 2016 by the Federal Administration for Drug Treatment and Addiction Services. Mental Health. A significant portion was stolen from health care providers, according to the survey.
The same survey shows that narcotics are rarely stolen from a doctor, clinic, hospital or pharmacy. Less than 1% of respondents reported purchasing opioids in this way.
Pamela Palmer, co-founder of AcelRx and director of medical services, said she launched the company after becoming aware of the large number of hospital deaths caused by misdiagnosis of opioids. An anesthetist herself, Palmer, said that doctors and nurses made these mistakes by calculating the amounts of liquid analgesics such as morphine to administer to patients by intravenous infusion.
A pre-dosed, short-acting pain reliever in the form of a pill would help reduce this rate of error and save lives, she said. Dsuvia would also quickly reduce pain because it is placed under the tongue, not swallowed and quickly enters the bloodstream, she said. The company has already approved versions 15 and 30 micrograms of the pill in Europe, she said.
A single Dsuvia would have the same impact as five milligrams of intravenous morphine, Palmer said. Each tablet would be supplied in a single-use plastic cartridge that would look like a syringe, which would prevent patients and caregivers from dispensing more than one at a time.
"We have done [the pill] small for two reasons: you want the solution to dissolve quickly and we do not want to create by reflex a large production of saliva "that could affect the effectiveness of the drug, she said. The small tablet dissolves in six minutes and the pain relief lasts an average of three hours, Palmer said.
The US military is interested in tablet for pain relief on the battlefield and has funded some of the company's research, according to public documents.
The FDA does not comment on the drugs under review, but one spokesperson said, "The FDA advisory committees provide the agency with independent and expert advice on a range of complex scientific, technical, and policy issues. . This includes issues related to the development and evaluation of products regulated by the FDA. "
In their letter, Public Citizen and Brown also complained that some members of a separate FDA advisory committee on drug safety had not been invited to the October 12 meeting. , which skewed the vote on Dsuvia.
The FDA said some of these people also could not attend because of scheduling conflicts.
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