US regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.
The decision by the Food and Drug Administration (FDA) came over objections from critics who fear the pill form of sufentanil, which is 1,000 times more powerful than morphine, will be abused.
In a lengthy statement, FDA Commissioner Scott Gottlieb said there will be ‘very tight restrictions’ placed on its distribution and it is intended only for supervised settings like hospitals.
The pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield, but now it will be available as a single, dissolvable dose for patients in the hospital, at just $50 to $60 a tablet.
On Friday, the FDA approved a dissolvable pill form of sufentanil, a potent opioid that will be placed under the tongues of patients in pain in hospitals – despite outcry from many doctors
The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor.
Gottlieb noted the pill was a high priority for the Department of Defense, which helped fund testing, because it wanted a way to provide fast pain relief to injured soldiers.
The tablet, placed under the tongue with a dispenser, starts reducing pain in 15 to 30 minutes.
A panel of FDA advisers had earlier voted 10-3 in favor of the pill called Dsuvia.
But in a rare response, the panel’s chairman joined critics in urging the FDA to reject it.
The chairman, Dr Raeford E Brown Jr, who couldn’t attend the meeting and didn’t cast a vote, predicts that the pill will be abused inside and outside medical settings and cause overdose deaths.
The pill is a new form of sufentanil, a chemical cousin of the opioid fentanyl.
Gottlieb said the drug will carry a boxed warning and won’t be available at drugstores for patients to take home.
Instead, doctors will administer a single dose under the tongues of patients in pain in hospital settings.
But Dr Brown worries that isn’t enough control over the drug.
‘Because the drug is used in a sublingual’ – or under the tongue – ‘form, it will be rapidly absorbed by the vasulature under the tongue,’ Dr Brown told Daily Mail Online in a recent interview.
He worries that this mechanism could lead to accidental overdoses that might be made worse if patients chewed the drug, accelerating its absorption into the bloodstream.
Plus, just because they are supposed to use Dsuvia when and how its given, doesn’t mean they will, Dr Brown worries.
‘Patients don’t always do the right thing with a drug,’ he said.
He added that AcxelRX’s assurances that their drug’s design will keep it from being abused shouldn’t carry much weight.
‘Just because a company says, “we’re only going to allow the drug to be used in way X” doesn’t mean it’s true,’ said Dr Brown.
‘I learned that the hard way.’
The FDA’s promises during the drug’s review process didn’t inspire much confidence in Dr Brown, either.
‘[The FDA] has put together a program that hasn’t thus far found any reliable risk mitigation strategy that is effective in preventing misuse and diversion of these agents,’ he said.
Acknowledging the criticism, he said he’s asked FDA staff to ‘evaluate a new framework’ for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.
‘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,’ Gottlieb wrote.
Sidney Wolfe of Public Citizen’s Health Research Group, a consumer group, called Gottlieb’s statement ’empty rhetoric’ and said the agency missed a big opportunity when it approved the pill.
‘It’s a huge mistake,’ Wolfe said.
‘This drug is doomed. It’s dangerous and it will kill people.’
The California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.
In one study, the pill provided about the same pain relief to patients as IV morphine. Common side effects with Dsuvia included nausea, vomiting, constipation and decreased blood oxygen levels. Those occurred slightly more often with the pill than for study participants given morphine.