The U.S Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee just voted last month to approve Dsuvia, a new medication that contains a powerful synthetic painkiller known as sufentanil. It was created by a California-based company, AcelRx Pharmaceuticals, and on November 2nd of 2018, it passed the FDA vote for approval.
In a perfect world, this type of news wouldn’t be met with controversy. However, physicians, recovery groups, those who struggle with opioid abuse and their families are just a few of the impacted populations that have voiced their concerns regarding such a strong new painkiller. “The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid,” said the public advocacy group Public Citizen in response to the approval, and Democratic Senator Ed Markey of Massachusetts urged the FDA not to approve the painkiller last month, saying “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.”
The blame for the opioid epidemic goes back and forth, ranging from the physicians who prescribe opioids, the pharmaceutical companies that created the drugs, and the individuals who abuse them. AcelRx does its best to put our minds at ease, promising limited access and strict guidelines to the availability of Dsuvia. “DSUVIA will not be available in retail pharmacies or for outpatient use. DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA.”
These restrictions may, for a time, keep Dsuvia in its appropriate clinical setting, but so did the restrictions that came before it in regards to some of the most commonly abused narcotics to date. The real question is whether Dsuvia is medically necessary, especially considering the amounts and strengths of opioid pain killers currently available to physicians inside emergency rooms, oncology wards, and pain management clinics. Medications such as morphine, fentanyl, and hydromorphone are found in every hospital, and pain relief for patients can usually be administered within a few minutes intravenously. The justification for Dsuvia is that since it is administered in a sublingual tablet with an applicator, it will eliminate the need to set up an IV in patients needing immediate pain relief. “The approval of DSUVIA, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” said Vince Angotti, Chief Executive Officer, AcelRx. “We believe the unique features of DSUVIA are an important leap forward in the management of acute pain and patient care in these settings.”
While this may seem to be a noble idea, creating a medication that is reportedly 1000 more potent than morphine, and ten times stronger than fentanyl seems a strange priority for a country that on October 26th of 2017, declared the opioid crisis a national public health emergency under federal law.
With the opioid epidemic sweeping across the nation, many initiatives have been put into place in order to combat the loss of life, such as supervised use sites, easier availability to overdose-reversal drugs such as Narcan, and federal funding being allocated to states in order to address the crisis. Increasing awareness to resources such as support groups, counseling, residential/ outpatient therapies, medication assisted treatment and other social services will be crucial to help alleviate future suffering by those affected by substance abuse.
