The Food and Drug Administration, on November 2, 2018, announced its approval of a new synthetic opioid tablet that’s 1,000 times stronger than morphine and 10 times more powerful than fentanyl.
- Sufentanil will be sold in pill form under the brand name “Dsuvia.”
- It been available for intravenous use since the ’80’s.
- As with the liquid form of the drug, the pill is only to be administered in hospitals, emergency rooms and surgery centers.
The drug maker, AcelRx, believes the 30-microgram tablet, which is pre-packaged inside a small plastic applicator that allows health care workers to dispense the drug under a patient’s tongue, will eliminate intravenous dosing errors.
“If you’ve got solid dosing like in a tablet, [potency] doesn’t matter,” AcelRX founder and Chief Medical Officer Dr. Pamela Palmer told the Business Times. “If you’ve got a clear liquid, that’s not a discreet dosage form.”
The Case Against
The FDA rejected approval just last year and the agency’s about-face on the medication has kicked up a storm of controversy amidst the ongoing crisis of opioid overdose deaths in the United States.
- An estimated 72,000 Americans died from drug overdoses in 2017, the vast majority of those were opioid related.
Critics of the approval point to the deadly synthetic opioid fentanyl. Though fentanyl is only supposed to be administered in hospitals, emergency rooms and surgery centers, it is widely produced in illegal, underground labs in various parts of the world and is responsible for untold thousands of deaths.
“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,” Massachusetts Senator Edward J. Markey said in a statement to the FDA, after the agency approved the medication.
What’s more, a report from the Drug Enforcement Administration, which came out on the same day as the FDA’s approval of this drug, finds that prescription drugs, including opioids such as fentanyl and prescription painkillers, are responsible for the majority of overdose deaths since 2001.
“This report underscores the scope and magnitude of the ongoing opioid crisis in the United States,” Acting DEA Administrator Uttam Dhillon said in a statement.
Though he’s come under fire from prominent voices in the healthcare industry, addiction experts and government officials, FDA Commissioner Scott Gottlieb stands behind the agency decision to approve this new painkiller amidst the ongoing opioid crisis. Among the various reasons Gottlieb cites is the ease in which the drug is administered to patients who might be unable to swallow or receive an intravenous injection, most notably wounded American soldiers on the battlefield.
“This opioid formulation, along with its unique delivery device, was a priority product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” he said in a statement.
AcelRx, the drug’s maker, projects that the medication will be commercially available by early 2019 and the medication will improve the standard of care for patients suffering from acute pain. Whether or not enterprising, underground chemists will attempt to produce their own version of the drug for sale on the black market is to be seen.
Similar to fentanyl, the potential side effects of this new drug can include:
- Extreme tiredness
- Cardiovascular suppression