The FDA approved a strong new opioid, although there were serious doubts about the safety and need for the drug from those affected by the country's opioid epidemic including the opposition of the chairman of the FDA committee who recommended it Approval of the drug.
Dsuvia is a sublingual formulation (that dissolves under the tongue) of the potent opioid sufentanil, a more potent form of fentanyl approved for intravenous and epidural use since the US According to a press release of November 2, 1
The drug is administered in 30 mcg doses via a disposable container dosing device. However, it is intended for medical use only in medical facilities (such as hospitals), which means that it is not something that you can pick up at your pharmacy with a prescription from your doctor.
Dsuvia should be used only in patients who have not responded to other pain medications.
"The drug is given in a stable form that makes it ideal for certain special circumstances where patients may not be able to swallow oral medications and access to intravenous pain relief is not possible," says Dr. Gottlieb in his statement. In his opinion, the drug is best for patients whose pain can not be adequately treated with other medicines, or for those who can not tolerate these medicines.
He also points to the military potential of Dsuvia and points out that the Ministry of Defense has worked closely with AcelRx, the maker of Dsuvia. "The FDA's mission is to ensure that our soldiers have access to treatments that meet the specific needs of the battlefield, even though intravenous administration is not possible to treat acute pain associated with battlefield wounds," he says. 19659007] Critics argue, however, that Dsuvia's potential value does not outweigh its risks.
"There is no unique place in the current armamentarium for analgesics." Raeford Brown, chair of the Anesthetics Anesthesia and Analgesics Advisory Committee (AADPAC), the FDA body tasked with evaluating such drugs, announces SELF. (Dr. Brown, a professor of anesthesiology and pediatrics at the University of Kentucky and the Kentucky Children's Hospital and chair of the Department of Anaesthesiology and Pain Medicine at the American Academy of Pediatrics), was due to vote at the AADPAC in October earlier pledges, but co-author of a bold appeal letter on the FDA's decision with a group of health experts at the Non-Profit Organization for Consumer Representation Public Citizen . Brown asks how many patients can not be adequately treated in any of the currently available 440 formulations – including Abstral a comparatively potent drug for the treatment of breakthrough pain associated with cancer, and so is demand really more serious after more opioids.
"To think that we really need another [opioid] is a stretch", Timothy Brennan MD, director of the Addiction Institute at Mount Sinai West and Mount Sinai St. Luke's Hospitals and head of the Fellowship in Addiction Medicine program at the Icahn School of Medicine Mount Sinai, tells SELF.
And in the context of the current opioid epidemic, experts fear that another effective drug like this might have real human costs. "We as a country devour opioids at much higher rates than any other country, and if we introduce another opioid in the midst of the American opioid crisis, that contradicts reason," says Dr. Brennan. "Fentanyl and its analogues are being misused, abused, and entering the illegal opioid supply," he continues. "The fear as an addiction doctor is that this product [do the same] will lead to an overdose."  The high potency of Dsuvia particularly affects him. "What me and I think many others in medicine are about this product is that it's so toxic – it's many times stronger than other conventional opioids like morphine."
The FDA says it imposes "very strict restrictions" to prevent the abuse and abuse of Dsuvia in the face of the rampant opioid problem.
"We have learned much from the harmful effects that other oral opioid products may have on the opioid crisis. We have used these tough lessons as part of our steps to address Dsuvia's safety concerns, "said Dr. Gottlieb's statement of November 2.
In accordance with FDA requirements, AcelRx has provided a risk assessment Mitigation Strategy ( REMS) to address these concerns. "It can not be given to patients for home use and should not be used for more than 72 hours and it should only be administered by a healthcare provider using a single-dose applicator," the statement said by Dr. Gottlieb, "These measures to restrict the use of this product only within a controlled health environment and not for home use are important steps to prevent abuse and abuse of Dsuvia and reduce the potential for distraction."
The FDA also points out that Dsuvia, like all opioids, is a box with the warning both about the serious potential side effects of the medicine (including respiratory depression, coma and death) as well as the potential for abuse. The FDA will also carefully monitor the implementation of REMS and "work to make regulatory adjustments quickly if problems arise."
However, skeptics point out that other opioids that are currently misused, such as fentanyl, are similarly severely restricted , "Historically, the situation is [that]." We could not control any other opioids, "Dr. Brown. "I have no confidence that sufentanil would be more successful," adds dr. Brennan added.
The controversy surrounding the approval of this drug is part of a larger issue that the FDA – and the country – are currently facing
"We will be what I believe to be the real cause of dissatisfaction among the critics of this approval is, can not handle "- the question of whether America needs another potent opioid in a serious addiction crisis or not." Dr. Gottlieb says in his statement: "This important issue has cropped up in previous approval decisions and will re-emerge in the future. As a health authority, we have an obligation to address this issue openly and directly. " Dr. Gottlieb says that although the FDA evaluates each new drug based on its own merits, the agency is working to address broader public health concerns such as the opioid crisis to take into account, and notes that Congress last month granted Congress an FDA "novel and specific authorities" to regulate the opioid market by, inter alia, imposing certain packaging requirements and conducting post-market studies However, there is obviously more to be done. "We need to be thoughtful and spend our money on developing non-opioid options so that people can get good, clinically significant acute pain control without having to Opioid-related problems, "says Dr. Brown," so that we do not stop in the US have old opioid crisis, we have to think about how we can use less opioids, not anymore. "