The US regulators approved a fast-acting, high-potency opioid tablet on Friday as an alternative to IV painkillers used in hospitals.
The Food and Drug Administration's (FDA) decision was met with criticism from critics who fear that the pill form of sufentanil, which is 1,000 times more potent than morphine, is being abused.
In a detailed statement, the FDA Commissioner Scott Gottlieb said that the distribution is imposed "very strict restrictions" and is intended only for supervised facilities such as hospitals.
The pill was developed as an option for patients who have difficulty in using infectious diseases, including soldiers on the battlefield. Now it is available as a single, dissolvable dose to hospital patients, for only $ 50 to $ 60 per tablet.
On Friday, the FDA approved a dissolvable pill form of sufentanil, a potent opioid that will cause pain to patients in hospitals – despite the outcry of many doctors
The pill from AcelRx Pharmaceuticals contains the same decades-old analgesic that is often given to surgical patients and women at work in the form of an intravenous injection or injection.
Gottlieb pointed out that the pill was a high priority for the Department of Defense, which supported the test funding, as it sought a way to allow injured soldiers a quick pain relief.
The tablet, which is placed under the tongue with a donor, begins to reduce the pain after 15 to 30 minutes.
A panel of FDA advisors had previously voted 10-3 for the pill called Dsuvia.
In a rare response, the jury chairman challenged the FDA's criticism of pushing the FDA to reject it.
The Chairman, Dr. Raeford E Brown Jr, who was unable to attend the meeting and had not cast a vote, predicts that the pill will be abused inside and outside medical facilities and lead to overdose deaths.
The pill is a new form of sufentanil, a chemical cousin of the opioid fentanyl.
Gottlieb said the drug will carry a box of warnings and will not be available in pharmacies so patients can take it home.
Instead, doctors administer a single dose under the tongue of patients suffering from hospital pain.
But Dr. Brown worries that control of the drug is not enough.
"Because the drug is used sublingually – or under the tongue – it is quickly taken up by the vasulature under the tongue," Dr. Brown said in an interview with Daily Mail Online recently.
He fears that this mechanism could lead to accidental overdoses that could be exacerbated as patients chew the drug and accelerate its uptake into the bloodstream.
Just because they should use Dsuvia, if and how it is given, does not mean that they will do that, Dr. Brown worried.
"Patients do not always do the right thing with a drug," he said.
He added that the assurances given by AcxelRX that the design of their drug would prevent it from being misused should not have much weight.
"Just because a company says, 'We'll just allow the drug to be used in X' does not mean it's true, 'said Dr. Brown.
"I learned it the hard way."
The FDA's pledges during the drug's review process have also been received by Drs. Brown did not trust that much.
"[The FDA] has put together a program that has not found a reliable risk mitigation strategy that effectively prevents abuse and distraction of these agents, "he said.
In recognition of the criticism, he said he had asked the FDA's staff to evaluate a "new framework" for the approval of new opioid medications, which clearly sets out how the agency rates benefits and risks.
"We are not deterred by what I believe to be the underlying cause of dissatisfaction among the critics of this approval – the question of whether America needs another strong opioid in a serious addiction crisis," wrote Gottlieb.
Sidney Wolfe of the Public Citizens' Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency had missed a great opportunity when they approved the pill.
"It's a big mistake," Wolfe said.
"This drug is doomed to fail, it is dangerous and will kill people."
The California company expects the pill to be available early next year at a cost of $ 50 to $ 60 per pill.
In one study, the pill provided patients with approximately the same pain relief as IV morphine. Common side effects with Dsuvia were nausea, vomiting, constipation, and decreased blood oxygen levels. These occurred a little more frequently in the pill than in study participants who were given morphine.