On Friday the Food and Drug Administration approved Dsuvia, an opioid that is 10 times more powerful than the controversial Fentanyl.
Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine". The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. 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.
According to Gottlieb, there are very tight limitations for the use of the drug.
In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders.
The FDA is taking some precautions in the hopes that the drug will not be abused.
As the worst drug crisis in USA 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 evaluating each opioid application on its own.
The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month.
Harvard claims rock zooming through solar system: sent by aliens
The Harvard paper will be published November 12 in The Astrophysical Journal Letters, NBC News reports . A new study as found a huge cigar-shaped object travelling through space could be an alien spaceship.
The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. "This drug just will work a lot more than morphine - it's 1,000 times stronger", she says.
"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.
The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. That panel recommended the drug's approval despite his warning. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.
"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds", he wrote.
"It's a huge mistake", Wolfe said. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
Including brand name and generic drugs, there are almost 400 opioids now on the market.