The opioid sufentanil has been used for many years in health care settings as an IV analgesic as part of balanced general anesthesia during surgery. The Food and Drug Administration (FDA) has now approved a new sublingual form of this drug under the trade name Dsuvia. It is intended for use in adults who have such severe pain that alternative opioids are inadequate. Dsuvia can only be sold and administered in certified medically supervised health care settings such as hospitals, surgical centers, and EDs.
Dsuvia is 10 times more potent than fentanyl and 1,000 times more potent than morphine, so extremely small doses are indicated. It must be administered by a health care professional and its use is limited to 72 hours. The maximum dose is 12 sublingual tablets (30 mcg each) per 24 hours. Each Dsuvia tablet already comes placed within a special applicator to ease its placement under the tongue, as well as to prevent accidental dispensing or refilling with a substitute tablet. Gloves should be worn during administration.
According to the manufacturer, Dsuvia dissolves in six minutes without triggering the production of saliva; this prevents swallowing of the drug. Patients who might benefit from Dsuvia include those for whom it is difficult to insert an IV device, such as older adults, obese patients, or patients with major burns.
Like all opioids, Dsuvia carries a black box warning regarding risk of respiratory depression; risk of addiction, abuse, and misuse; and risks from concomitant use with other medications such as benzodiazepines or other central nervous system depressants. The warning also states that concomitant use with cytochrome P-450 (CYP) isoenzyme CYP3A4 inhibitors (or, conversely, stopping drugs that induce this isoenzyme) can dangerously raise the circulating levels of Dsuvia and be fatal.
Other warnings and precautions listed on Dsuvia's label include the following: older adults, patients with chronic pulmonary disease, or cachectic or debilitated patients are at increased risk for life-threatening respiratory depression and require close monitoring; coadministration with serotonergic drugs can result in serotonin syndrome, which can be life threatening; adrenal insufficiency may occur with Dsuvia's use; severe hypotension can occur; and patients with increased intracranial pressure, brain tumors, head injury, or impaired level of consciousness are at risk for sedation and respiratory depression.
The drug was approved by the FDA's Anesthetic and Analgesic Drug Products Advisory Committee in a vote of 10 to three at its October 12, 2018, meeting. The approval, however, has been controversial, with many critics expressing concern that the drug could contribute to more opioid deaths. Although potency is not a concern when the drug is administered in a medical setting, its diversion from sanctioned settings could contribute to overdose deaths. The drug could be diverted through mismanagement of a "dropped dose" or it could be stolen.
Critics of the FDA's decision to approve Dsuvia include Raeford Brown, chair of the advisory committee that approved it; certain U.S. senators; and the general public. Brown took an unusual step and publicly offered his view that the drug would contribute to the opioid crisis in a letter to the FDA sent jointly with the consumer advisory group, Public Citizen. Brown felt that Dsuvia's high potency could make it a specific target for street use and predicted "diversion, abuse, and death within the early months of its availability on the market." (To read Brown's letter, see http://www.citizen.org/sites/default/files/2451.pdf.)
United States senators Edward J. Markey, Claire McCaskill, Joe Manchin III, and Richard Blumenthal protested Dsuvia's approval in their October 31, 2018, letter to FDA Commissioner Scott Gottlieb. They raised several concerns, including that the advisory committee meeting was held when Brown, who had expressed serious concerns about the product and its approval, was not there; that the FDA's full Drug Safety and Risk Management Advisory Committee was not involved in the approval; that the high potency and small size of the Dsuvia tablets would make them easy to divert; that the FDA had been "historically ineffective" with its opioid risk evaluation and mitigation strategies (REMS); and that there remains a lack of uniform opioid education planned for health care prescribers (see http://www.markey.senate.gov/imo/media/doc/letter%20to%20Administrator%20Gottlie).
Gottlieb also made an unusual public announcement about Dsuvia. In a November 2, 2018, statement (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624968.htm), he agreed that the agency should consider the broader public health implications of new drug approvals, not just the basic safety and efficacy of drugs requesting approval. He also stated that he had tasked the FDA to "evaluate a new framework for opioid analgesic approvals; one that provides a transparent process to delineate clearly, eventually in new guidance, how we intend to consider the benefits and risks of these products in the context of this crisis."
Gottlieb made the case, however, that Dsuvia's novel, sublingual route of administration offered a benefit to those who could not receive the drug via IV access, such as those on the battlefield or for whom circumstances made it difficult to insert an IV device, such as patients in a moving ambulance. He defended the decision to approve Dsuvia, citing that the REMS plan and limiting the drug's use to hospitals and health care facilities would decrease the risk of diversion and abuse.
Nurses should familiarize themselves with the pros and cons of Dsuvia use. Nurses can play an important role in their institution's decision about whether to stock the drug and in determining what efforts will be needed to prevent diversion if the drug is available.
For complete prescribing information, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209128s000lbl.pdf.