There’s a highly potent opioid on the market that you’ve likely never heard of: Dsuvia. This new drug, said to be upwards of 1,000 times more powerful than morphine, was developed with major funding for the Pentagon at a time when the opioid crisis was exploding in the U.S. While AcelRx Pharmaceuticals chief medical officer Pamela Palmer, who led development of Dsuvia, says the drug fills a need both for the military and for hospitals struggling with drug shortages — but critics including the FBI warn that it could lead to even more avoidable deaths.
- The opioid epidemic has grown out of control. Between 1999 and 2017, the rate of overdose deaths from prescription opioids rose 500%. Young and old, rich and poor, communities laid waste by drugs developed in sterile labs with the best of intentions. And now a powerful new opioid, Dsuvia, 1,000 times more powerful than morphine has hit the market. Advocates of Dsuvia say it addresses a military need, and that particularly now with the coronavirus pandemic driving shortages in some drugs, it could fill a much-needed niche in hospitals.
PAMELA PALMER: So nine years working with the Department of Defense on this. We actually went to the FDA. They said, we want you to do some more testing. But we did everything that they asked for, and they finally did approve it in November 2018. But certainly nothing in drug development ever occurs quickly, and that was the case with Dsuvia.
- Dsuvia was approved in a controversial ten to three vote by the FDA. But more than a year later, the military has yet to purchase the drug in large quantities. And now AcelRx is actively pursuing the civilian market.
ANDREW KOLODNY: We're hearing a story that there was a need for this product and that a pharmaceutical company was there to meet the need. I don't buy it. When a drug company gets its medicine approved by the FDA, it doesn't just sit on its hands and hope that doctors will prescribe this product that they invested millions in. They do everything they can to let the medical community know that this new product exists, and they do everything they can to get the medical community to prescribe this new product.
PAMELA PALMER: We started with a relatively small group of sales, and so the doctors who are talking to us are surgeons, emergency room physicians, folks who are really using this drug and seeing an advantage over what they typically use. But we're getting tremendously encouraging feedback from physicians who've used Dsuvia.
ANDREW KOLODNY: One of the problems with approving new opioids is public health agencies are trying to get the medical community to prescribe more cautiously. They're trying to get doctors to prescribe less opioids.
PAMELA PALMER: We're working with the FDA on a program that's called a REMS, or a Risk Evaluation Mitigation Strategy program, such that we follow every box of Dsuvia and know that it's been shipped to a medically supervised setting, and we survey and look for any source of leaks of Dsuvia outside, and we've not seen any to date.
ANDREW KOLODNY: What we're hearing is that there are safeguards and measures in place that will make it impossible for Dsuvia to have a negative public health impact. We've heard this before. We know that it didn't work.
We know that the vast majority of the patients who were getting the products were not the patients who were supposed to be getting these products. So no, the REMS failed. And I don't believe that the system that's supposedly going to protect the public from Dsuvia is going to work any better than that previous system.
PAMELA PALMER: But while that outpatient crisis is occurring, and has occurred, and will continue to occur to some degree until we can curb it, what's been going on in the hospital that I saw back in 1999 and eventually started this company to solve is a completely different crisis, and it's still ongoing, and that is medication errors. So the whole goal of our company is to try to solve that crisis and not add to the outpatient crisis.