The National Institute on Drug Abuse (NIDA) reported of patients undergoing long-term opioid therapy developed an opioid disorder. This is characterized by a strong urge to use opioid drugs, even when it is no longer part of the medication. But despite of increasing number of opioid abuse, why did the FDA approved yet another opioid drug?

Opioids are usually found on pain relievers such as fentanyl, oxycodone, hydrocodone, codeine, morphine, and even heroin. It attacks the human nervous system, giving temporary feeling of pleasure and relief from pain. Approximately 40, 000 deaths were accounted to opioid overdose last year; 30, 000 of which come from fentanyl and other synthetic opioids.

The FDA approval took place after the chairman of the advisory committee asked them to reject the drug (Dsuvia) due to the high chance of being abused. Dsuvia was found to be 10 times stronger than fentanyl — a drug that is often reproduced illegally and has brought thousands of deaths from overdose within the past few years.

Chairman of Committee, Dr. Raeford Brown, even wrote a letter addressed to top FDA officials to express his deepest concern. Although the vote was 10-3, in favor of the rejection, the FDA still pursued the approval.

The NY Times revealed some parts of the letter which are expressed below:

In the letter, which he wrote with leaders of the consumer 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 will encounter diversion, abuse and death within the early months of its availability on the market.”

Consequently, FDA commissioner, Dr. Scott Gottlieb, also released a statement about the FDA’s decision, acknowledging the crisis of opioid addiction, but defending the agency which he strongly emphasized that Dsuvia is delivered through a pre-filled, single-dose applicator which will only be administered in hospitals, surgical centers, of other medical facilities under strict supervision. Dr. Gottlieb even said that this novel drug is beneficial to soldiers wounded on the battlefield.

“…This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical 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. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee.”

Vince Angotti, the chief executive of AcelRx Pharmaceuticals, creator of Dsuvia, also released a statement assuring the public that they will diligently follow the risk evaluation and mitigation strategy — a safety program approved by the FDA, to monitor the distribution of the drug. This is to make sure that only hospitals and other licensed medical facilities can dispense the drug properly.

Dr. Brown, advisory committee head on analgesics and anesthetic drug products, who missed the voting process wrote a letter later, expressing his worry, “It is so potent that abusers of this intravenous formulation often die when they inject the first dose.” This led to Dr. Brown’s questioning of whether the FDA will succeed in administering the regulations they’ve established once the drug be available on the market.

“It is my observation that once the F.D.A. approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population” Brown added.

The NY Times also mentioned of Dsuvia approval critics which include four senators: Edward Markey, Richard Blumenthal, Claire McCaskill, and Joe Manchin. In spite of Dr. Brown’s absence in the committee, the FDA spokeswoman said that “…there were drug safety and risk experts on the committee whose expert input was taken very seriously throughout this process.”

Source: https://www.nytimes.com/2018/11/02/health/dsuvia-fda-opoid.html