In the Midst of Crisis, FDA Approves Opioid Drug 10X Stronger than Fentanyl Funded by DoD

  The FDA has approved the rollout of a new opioid drug up to 1000  times stronger than morphine, despite the opioid crisis that is  currently killing more Americans than any other cause of accidental  death.   The agency sided with its Anesthetic and Analgesic Advisory Panel,  which voted 10-3 to approve Dsuvia, a sublingual tablet form of  sufentanil, against the recommendation of its chairman. 

At 5-10 times  the strength of fentanyl, sufentanil is 500-1000 times stronger than  morphine, and will supposedly only be administered to treat acute pain  in medically-supervised settings. Fentanyl, too, is available only by prescription, yet a significant  quantity is manufactured in illegal labs or diverted to the street,  where it regularly kills opioid addicts who aren’t even aware they are  taking it. Dsuvia is fulfilling an “unmet need,” says Dr Pamela Palmer,  chief medical officer of AcelRx, which makes the drug. 

Because the drug  dissolves under patients’ tongues, it provides quick relief without the  use of an injection. Still, because it must be delivered in a medical  setting and doctors and nurses are trained to give injections, there are  relatively few situations in which it offers an advantage that  outweighs the risk of unleashing a powerful new narcotic onto an already  drug-saturated populace. The Department of Defense had a hand in funding the research that  produced Dsuvia, which could replace morphine on the battlefield due to  its ease of administration. AcelRx projects $1.1 billion in annual sales  and hopes to have its product on hospital shelves by early 2019. 

Dsuvia tablet and applicator © AcelRx

    Palmer claims the drug will be subjected to much stricter audits and  monitoring than earlier opioids like Oxycontin, which became so  ubiquitous in rural America after it was introduced by Purdue  Pharmaceuticals that it earned the nickname “hillbilly heroin.”  Drug manufacturers flooded small towns with millions of pills, filling  huge pharmacy orders out of proportion to the population of the  surrounding areas. With 200 million prescriptions already written for opioids every year  in the US, many argue Americans don’t need another drug. Dr. Sidney  Wolfe, senior adviser to Public Citizen’s Health Research Group,  dismisses Palmer’s claims about the fast action of Dsuvia: two studies  indicated patients only felt “meaningful” pain relief after 54 minutes and 78 minutes, making the new drug no better than swallowing a pill. Over 72,000 Americans died of drug overdoses last year – a new record  – and among the drugs causing overdose, the largest increase was in  fentanyl and fentanyl-like synthetics.