FDA OKs Powerful Opioid Pill as Alternative to IV Painkiller

Desiree Burns
November 5, 2018

Such committees weigh in on the safety and efficacy of proposed products, and the FDA generally follows committee guidance in its decisions about drugs.

As the worst drug crisis in US history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of ruling on each opioid application on its own. 'There are very tight restrictions being placed on the distribution and use of this product. "We've learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis", Gottlieb added. We've applied those hard lessons as part of the steps we're taking to address safety concerns for Dsuvia, ' he said.

'Patients don't always do the right thing with a drug, ' he said.

Opioids, including prescription opioids and heroin, killed 42,000 people in 2016, the CDC says. "And many of those will overdose and die", Sidney Wolfe, the founder of Public Citizen's Health Research Group, said in a statement. Brown chairs the FDA committee that, despite his disagreement, voted for Dsuvia's approval. The pill, called Dsuvia, from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. 'I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.' In discussing the rationale for the approval, however, Gottlieb argued that the different formulation and battlefield needs made it possible for the FDA to have Dsuvia fit into the 'overall drug armamentarium.' And while he acknowledged the criticism, he insisted the risk management program, known as a REMS, will ensure the drug is only used in a medically supervised settings.

"It will not contribute to the large outpatient opioid crisis", Palmer maintains.

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.

The company projects $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

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"It is not unique at all", Wolfe says, adding that the drug wasn't adequately tested in emergency settings, and that in tests, pain relief with Dsuvia was slow.

In one study, the pill provided about the same pain relief to patients as IV morphine. Brown, the committee chief, who has been outspoken against certain opioids in the past, says he was unable to attend the advisory committee meeting on October 12 because of a scheduling conflict that he had informed the FDA about months in advance.

Brown says the FDA chose to hold the meeting anyway - without him.

Gottlieb, however, said the FDA would do more to balance efforts to fight the epidemic with the needs of people who need strong painkillers. "My forthright nature may have played a role in their decision about how the agency was going to manage this advisory committee".

The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisors that it would inevitably be diverted to illicit use and cause more overdose deaths.

"In this way, 1/8drug companies 3/8 would know up front where the opportunities are for developing new drugs that meet the FDA's standards for safety and effectiveness", he wrote.

"That's not the full story", Brown says. Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect, ' said Dr. Raeford Brown, the FDA panel chair and a professor of anesthesiology and pediatrics at the College of Medicine at the University of Kentucky.

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