FDA on Friday approved a fast-acting, highly potent opioid tablet to serve as an alternative to IV painkillers typically used in hospitals, but some experts are raising concerns over the drug's potential to intensify the opioid misuse epidemic.
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The opioid, AcelRx Pharmaceuticals' Dsuvia, is indicated to treat moderate-to-severe acute pain. Dsuvia is a tablet version of an IV painkiller hospitals have used for decades to treat pain in patients who are in labor or undergoing surgery.
Providers administer Dsuvia, which will be available in a single-use package, by using an applicator to place the tablet under a patient's tongue, where it dissolves. The drug's side effects include breathing difficulties, coma, extreme fatigue, and death.
According to MedPage Today, the drug was tested in a randomized placebo-controlled phase III trial involving adults who underwent abdominoplasty, open inguinal hernioplasty, or laparoscopic abdominal surgery. The trial found Dsuvia led to a 12.7-point reduction in summed pain intensity scores from baseline when compared with a placebo. According to the results, 27% of adults who took Dsuvia required so-called "rescue" pain medication within the first 24 hours after their surgery, compared with 65% of patients who took a placebo.
According to USA Today, the drug "is 1,000 times more potent than morphine and 10 times stronger than fentanyl."
Based on the data, FDA on Friday approved the drug under the condition that AcelRx Pharmaceuticals comply with a Risk Evaluation and Mitigation Strategy to limit the drug's distribution.
Under the approval, Dsuvia will be available only for limited use in health care settings, including emergency departments, hospitals, and surgery centers. Dsuvia will not be available for use at home and will not be sold at retail pharmacies. AcelRx Pharmaceuticals is expected to begin selling Dsuvia in the United States in early 2019 at a price of $50 to $60 per pill.
However, some experts say questions remain about the drug's safety and usage directions—two factors that prompted FDA last year to reject Dsuvia's application.
Raeford Brown—a professor of anesthesiology and pediatrics at the College of Medicine at the University of Kentucky and chair of FDA's Drug Safety and Risk Management Advisory Committee, which was not involved in the agency's approval of Dsuvia—said concerns about the drug's limited amount of safety data and usage directions have not yet been addressed. "The lack of efficacy data and the (manufacturer's) inadequate response to safety concerns have not been addressed since [FDA rejected the drug] in 2017," he said.
Others have raised concerns that the drug's approval could worsen the opioid misuse epidemic.
According to "Pharmalot," Sens. Richard Blumenthal (D-Conn.), Edward Markey (D-Mass.), Joe Manchin (D-W. Va.), and Claire McCaskill (D-Mo.) in a letter sent last week to FDA Commissioner Scott Gottlieb argued that Dsuvia does not offer any new medical benefits when compared with medications already on the market, and warned that medical personnel could divert Dsuvia for improper use. The senators also criticized FDA for not convening a meeting with the Drug Safety and Risk Management Advisory Committee to discuss the drug's safety and effectiveness.
Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and serves as the executive director of Physicians for Responsible Opioid Prescribing, said, "There is absolutely no need for this product. Claiming we need it on the market to help soldiers on the battlefield is ridiculous. We already have sublingual fentanyl product available for use on the battlefield."
Sidney Wolfe, senior adviser at Public Citizen Health Research Group, said, "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die."
But Gottlieb said FDA has "learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis," and has "applied those hard lessons as part of the steps [it's] taking to address safety concerns for Dsuvia." He noted, "There are very tight restrictions being placed on the distribution and use of this product."
FDA said Dsuvia's "unique features"—particularly the drug's formulation as a tablet—make the opioid useful for the military. Gottlieb said, "FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds."
Gottlieb also said FDA is changing how it evaluates opioids. He explained that the agency is launching a "comprehensive process" to create a formal benefit and risk framework to help the agency determine whether opioids are safe and effective.
Further, Gottlieb said FDA is considering how opioids will affect both individual and public health while reviewing the drugs. He said, "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits. We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval—the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction" (May, USA Today, 11/5; Silverman, "Pharmalot", STAT News, 11/2; Hlavinka, MedPage Today, 11/2; AP/Modern Healthcare, 11/2; Baker, "Vitals," Axios, 11/5; Senators' letter, 10/31).
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