In early November, despite concerns and criticism, the Food and Drug Administration approved a new powerful opioid painkiller that is described as 10 times more powerful than fentanyl, which is 50 to 100 times more powerful than morphine. The passage of the new drug comes as the country is experiencing an opioid crisis that causes almost 30,000 overdoses per year. The crisis has been brought to the national spotlight over the past decade and has been one of President Donald Trump’s major talking points during his presidency so far.
The FDA Commissioner did acknowledge the risks of introducing a new, strong opioid during the current landscape but ensured the public that there will be steps and measures taken to reduce the potential of misuse and abuse of the drug.
Still, politicians and even other FDA officials were opposed to the approval of the drug and expressed their objections in a number of letters sent to the the FDA Commissioner.
What is Dsuvia?
The new drug, Dsuvia, is a 3-millimeter-wide tablet that first went before the FDA advisory committee in October. It is taken under the tongue through a disposable, pre-filled, single-dose applicator. After taking the drug, it is absorbed rapidly into the bloodstream. The drug would be used in a similar fashion as morphine or fentanyl, but only in specific situations that call for it.
Dsuvia is a form of sufentanil. Sufentanil, first synthesized in the 1970s, is a highly potent opioid that is administered intravenously and is known to be lethal even in small doses. Dsuvia is sufentanil except it is administered orally rather than through injection into the veins.
Following the passage of Dsuvia, AcelRX, the pharmaceutical company that developed the drug, released a statement.
"The FDA approval of DSUVIA is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings," said Dr. Pamela Palmer, Co-Founder and Chief Medical Officer, AcelRx. "As an anesthesiologist, I've seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients' acute pain.
FDA Commissioner Scott Gottlieb said in a statement that the new opioid would have “strong limitations” placed on the distribution and use of the drug in an attempt to inhibit misuse. Some of the restrictions that will be placed on Dsuvia include:
- It can’t be dispensed to patients for home use
- It should not be used for more than 72 hours
- It should only be administered by a health care provider using a single-dose applicator, this means it won't be available at retail pharmacies
- Only reserved for use when other alternative pain treatment options have not worked properly
Dsuvia will also carry a box warning about the serious risks associated with the misusing or abusing the drug which can lead to addiction and overdose. Other risks that come with the drug include:
- Extreme sleepiness
- Respiratory depression
Gottlieb stressed in his letter that the drug is purely to be used in a supervised health care setting and not for home use and instead should be used only in select circumstances
“These measures...are important steps to help prevent misuse and abuse of Dsuvia.”
The FDA describes the drug as unique as it doesn’t need to be swallowed for the effects to begin, making it ideally suited for certain special situations. One specific example of this is 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,” Gottlieb said.
The FDA press release said that Department of Defense worked closely with the sponsor on the development of the medicine.
"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.
During the process the FDA takes to approve drugs came warnings and after the approval came criticism including from its own agency.
The advisory committee that helped decide on approving the drug is put together to weigh in on the safety and effectiveness of proposed products. They then give their approval or disapproval and the FDA leans whichever way the committee decides. In this case, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 10-3 to approve the new drug which was later approved entirely by the administration.
Despite the passage of the drug, Dr. Raeford Brown, the chair of the AADPAC’s publicly opposed the opioid and asked the board to reject the new drug, even penning a letter to the commissioner and directors of the FDA.
“I have been involved in the assessment of countless opioid products over the last four years,” Brown said. “It is my observation that once the FDA 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 relative to its benefit to the public health.”
Furthermore, Brown was also absent the day that the committee voted on approval.
Another criticism about the advisory committee process came from four United States senators who wrote a letter to Commissioner Gottlieb. The letter said that during the review process, the FDA didn’t do all they could to evaluate the risks that this drug holds to the public and it is putting the country’s health at more of a risk to the opioid epidemic.
Specifically, they say that in past opioid reviews, the AADPAC would also bring in the FDA’s Drug Safety and Risk Management Advisory Committee (DSaRM) to be involved in the approval process. However, in the case of Dsuvia, the FDA did not bring in the DSaRM and, therefore, probably do not know the full addiction, abuse and dependence risks that may be associated with the new drug.
“DSaRM review of a new drug application is intended to ensure that, during the approval process, the potential risks of the drug are discussed and considered. Convening a joint meeting of the full AADPAC and DSaRM would have signaled that the FDA was fully exploring the relationship between Dsuvia’s risks and benefits. Not empaneling both committees jointly was a missed opportunity to demonstrate that the FDA is committed to fighting the opioid epidemic and that it has learned from past mistakes.
There is an obvious risk when it comes to approving these highly potent opioids as damage has already been felt around the country from them. The opioid crisis is a problem that is discussed constantly on Capitol Hill, in fact, four senators wrote to the FDA commissioner advocating against the new opioid. The epidemic has taken the lives of hundreds of thousands while millions other feel the effects.
One of the five issues addressed on the White House website is the Opioid Crisis. In October of 2017, President Donald Trump declared the opioid crisis to be a national public health emergency and directed executive agencies to fight the epidemic.
The President has taken steps in the past to try to make an impact on the problem. In March, Trump signed the Initiative to Stop Opioid Abuse that addressed factors like over-prescription, primary prevention and recovery support services. More recently, Trump signed the SUPPORT for Patients and Communities Act. The new law looked to tackle many aspects of the opioid problem, including preventing addiction for seniors, expanding oversight of prescriptions, combat opioid-related infectious diseases and much more.
“In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour,” Trump said during his 2018 State of the Union address. “My Administration is committed to fighting the drug epidemic and helping get treatment for those in need. The struggle will be long and difficult — but, as Americans always do, we will prevail.”
Despite, the national attention and steps taken to try and counter the opioid crisis over the past few years, the FDA believes that, while there is a major problem with opioids that the country is experiencing, Dsuvia can be helpful if given proper restrictions.
In a statement following the passage of the new opioid, FDA Commissioner Scott Gottlieb said, “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.”
In his address, Gottlieb did acknowledge the impact of the opioid crisis and the need for the FDA and other government agencies to curb the distribution and reduce the risk associated with drugs, especially those approved by the FDA.
In his statement, Gottlieb listed a number of specific questions that the FDA will look at for Dsuvia and the opioid crisis overall, including:
- How does the availability of an additional opioid benefit the public health?
- Does the approval of another opioid create added risks of diversion, overdose, abuse and other risks?
- If the approval of another opioid does increase risks, will the new drug still provide benefits to certain groups of patients in a way that the benefits outweigh the risks?
He said that to address some of the safety concerns associated with the drug, the FDA will require a Risk Evaluation and Mitigation Strategy to accompany the new opioid. The point of REMS is to manage specific risks of drugs that can be effective but are associated with potential or known risks.
The REMS that will be associated with the product will “tightly control its distribution and use” and “restrict Dsuvia’s use to certified medically-supervised health care settings”.
Gottlieb said that the FDA will monitor the REMS and will work quickly to make adjustments to regulations if problems come up.
However, in their letter from the four senators, they pointed out the “historical ineffectiveness of opioid [REMS] and the lack of uniform opioid prescriber education”. In a study done by the Department of Health and Human Services, the FDA determined that out of 49 REMS they looked at only 7, or 14.2 percent, were meeting all of their goals. The FDA determined that they were failing to meet all of their goals mostly due to the lack of awareness by prescribers and patients on the risks of the drugs involved.
If Gottlieb is relying on REMS to help assess and evaluate the risks of the new, powerful opioid, the FDA will have to be more reliable and timely with the risk recommendations that they receive from REMS.
Still, many do not have faith that the FDA will be able to completely control the new drug.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, senior adviser at Public Citizen Health Research Group told StatNews. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.
Dsuvia is scheduled for commercial release in the first quarter of 2019. The potential negative effects of the will not be visible for a time after the release of the drug.
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