In a move that went against the recommendations of Dr. Raeford Brown, chairman of the FDA advisory committee for evaluation of analgesic products, the U.S. Food and Drug Administration on Friday approved Dsuvia as a fast-acting substitute for intravenous painkillers used in hospitals across the nation.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) had voted 10 to 3 favoring the approval last month in a meeting that Dr. Brown was unable to attend due to prior commitments.
However, in a letter addressed to top FDA officials, including FDA commissioner Dr. Scott Gottlieb, Dr. Brown expressed serious doubts about the agency’s ability to regulate the potentially dangerous opioid in a manner that ensured its use “only in closely controlled settings” and appealed to them to reject it.
Writing on behalf of the non-profit consumer advocacy organization Public Citizen, De Brown suggested that the only way forward was the education of all prescribers about the potential dangers of abuse of the sublingual medication – something he said the FDA had failed to establish with other opioids.
“Given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label,” he said in the letter, signed by three other Public Citizen members.
Manufactured by California-based AcelRx Pharmaceuticals Inc., Dsuvia is the brand name for the drug sufentanil – an opioid believed to be 1,000 times more effective than morphine and 10 times more potent than fentanyl.
“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group and one of the signatories of the letter.
“It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die,” he said without mincing his words.
“It is likely, if not certain, that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms,” Dr. Wolfe added.
Sufentanil has been in use since as far back as the early eighties, but only as an intravenous agent by clinicians in hospital settings, and is known to have killed abusers with their very first dose.
The opioid is extremely potent and poses “substantial risks of respiratory depression, diversion, abuse, and death,” explains Dr. Brown.
“I have witnessed this in resuscitating physicians, medical students, technicians, and other healthcare providers, some successfully, as a part of my duties as a clinician in a major academic medical center,” he said.
Justifying the FDA’s decision to approve Dsuvia, Dr. Gottlieb said that the agency’s decision was an effort to fight the opioid epidemic that the nation has been confronted with for some time now.
He said that the medicine would be administered by healthcare professionals in certified medically-supervised health care settings, including hospitals, surgical centers, and emergency departments.
He assured that stringent restrictions were being imposed on the distribution and use of Dsuvia, saying that the agency had “learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis.”
“We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug,” he said.
Opioid prescribing, opioid dependence and opioid overdose deaths have been on the rise in the U.S. and have increased four times in the last three decades.
Medicare-insured senior citizens are the most affected by this opioid over-indulgence and it wouldn’t be an overstatement to say that the crisis has taken epidemic proportions.
The elderly are more susceptible to the risks involved not only in the protracted use of opioids and opioid overdose but also when low-intensity opioids are administered over shorter periods of time.
This is because of their vulnerability to the sleep-inducing side effects of the drug, with most Medicare seniors having a history of falls, fractures and broken bones.
In a move to counter the deepening opioid crisis in the country, President Trump had said last year that he was seriously considering the option of declaring a national emergency in that regard.
“It’s a national emergency. We’re going to spend a lot of time, a lot of effort, and a lot of money on the opioid crisis,” Trump had told reporters at his Bedminster golf club in New Jersey.
“It is a serious problem, the likes of which we’ve never had. You know, when I was growing up, they had the LSD, and they had certain generations of drugs. There’s never been anything like what’s happened to this country over the last four or five years,” he said.
Meanwhile, AcelRx CEO Vince Angotti has said that the company would strictly adhere to an FDA-approved safety program, referred to as Risk Evaluation and Mitigation Strategies program, which involves proper regulatory measures such as distribution monitoring, auditing wholesalers, and ensuring that hospitals and health care providers follow the set norms.
“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,” Angotti said.
“We believe the unique features of DSUVIA are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of DSUVIA through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”