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(RNN) – The FDA is considering approving a new form of pill of a potent opioid that the chairman of an advisory committee who voted in favor of its approval has described as "a danger to public health in general".
The FDA will decide by November 3 to allow or not the pharmaceutical company AcelRx to start producing Dsuvia, a new sublingual form (taken under the tongue) of sufentanil, an opioid considered to be more potent than the fentanyl, one of the essential drugs to the opioid. crisis.
Sufentanil has always been administered primarily intravenously (IV). The company argued that this new version, designed to be taken under medical control only by a single-dose applicator, is needed as a non-invasive and rapid alternative to intravenous opioids.
An advisory committee of the FDA voted 10-3 for its approval earlier this month. A version called Dzuveo has already been approved by the European Commission.
But the chair of the FDA committee, Dr. Raeford Brown, is strongly and publicly dissociated.
In a statement last week by Public Citizen to FDA administrators who will ultimately decide on Dsuvia's fate, Brown said allowing the drug to be produced in smaller, more portable tablets would likely have unintended consequences. .
Brown warned that it would be very difficult to strictly ensure a correct and legal distribution of the drug, which the FDA has not been able to do before with opioids.
"The agency believes that there is a capacity, not demonstrated so far, to regulate this drug so that it is only used in tightly controlled settings," Brown wrote. "For this to happen, the education of all prescribers should be ensured. This has not been demonstrated with any other opioid and … there is currently no educational or regulatory system that will guarantee that this drug will be used only as described in the label. "
Brown predicted "we will encounter diversions, abuses and death in the first few months of its availability on the market".
"Sublingual sufentanil is a danger to public health in general and will make our job of protecting Americans more difficult," he concluded.
Other doctors insisted that the distribution of the drug could actually be managed by professionals.
"Even though we are in the midst of an opioid crisis, my understanding is that it will only be administered by health professionals working in a hospital or similar institution," said Dr. Jeff Gudin, Director of Management. pain and palliative care in New Jersey. hospital, said MD Magazine.
He approved the vote in favor of Dsuvia's approval and stated that he could "meet an unmet need" in the treatment of pain.
Dr. Ronald Litman of Philadelphia Children's Hospital, who voted in favor of this opinion, told BuzzFeed News that "it could be useful in emergency rooms or if four of our soldiers are on the spot of battle "if they can not obtain a favorable opinion. IV
Pamela Palmer, Chief Medical Officer at AcelRx, argued that the relatively lower dose of this product would mitigate its misuse.
"I do not think others would like it – it would not produce the effect that illicit drug users are having at such a low dose," she told BuzzFeed.
An information document for the October 12 meeting, where the advisory committee approved the drug, indicates that the FDA's Controlled Substance staff has concluded "that the main risks associated with Dsuvia are an overdose of". opioids and unauthorized access to the product for the purpose of abuse and misuse.
And the risk assessment of the drug by the body (formally a risk assessment and mitigation strategy, or REMS) did not "specifically address the risks of abuse. , misuse and dependence, because this product would be used exclusively in hospital ", even if the drug was tested outpatient.
And a company press release a week ago quoted a professor at the Medical Center at the University of Minnesota, Dr. Jacob Hutchins, touting the benefits of this drug because "pain is the main cause of delay in the outpatient surgery centers and the main reason for an unexpected hospital. admissions. "
The FDA also has a long history of controlling the spread of opioids once they are on the market.
A survey conducted by InvestigateTV last month revealed that "the FDA had yielded virtually all control" of a fentanyl nasal spray product monitoring program to manufacturers of these same products.
These drug manufacturers "then" failed to prohibit doctors who had committed repeated offenses from prescribing drugs.
"The weak application of the law had consequences: the majority of patients who were prescribed powerful drugs were not eligible and some of them died," the survey revealed. "Drug manufacturers have prospered through the sale of high-priced drugs."
Dr. Brown emphasized the "lack of historical ability of the FDA to enforce controls" as one of the reasons he "would never consider this product for commercialization in the United States."
Dsuvia, warned the Public Citizen's letter, "will only add to the worsening and not to the mitigation of the opioid epidemic in this country".
Copyright 2018 Raycom News Network. All rights reserved.
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