Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill".
"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 said in his written statement. The pill is placed under the tongue for quick absorption and has the same impact as five milligrams of intravenous morphine, reported The Washington Post. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.
At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.
The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused.
According to Gottlieb, there are very tight limitations for the use of the drug.
According to a prepared statement from AcelRx, in a randomized, double-blind, placebo-controlled clinical study, which enrolled 161 patients, ages 18 to 69 years, the medication demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. The single-strength tablet and single-unit packaging are created to mitigate the possibility of dosing errors, misuse and diversion.
Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. Further, the drug will be limited for use in patients whom other analgesics were not tolerated, or are not expected to be tolerated. The numbers say it all: More people die in the U.S. each year from drug overdoses than from breast cancer. Most of that was the result of a record number of opioid-related deaths. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.