Dsuvia Makers Believe It Could Save Lives, Despite FBI Warnings

Controvery Over Dsuvia

The creators of Dsuvia, a new opioid 10 times stronger than fentanyl, have claimed it will save lives, but many critics believe it should not have been approved in the first place. The drug was initially funded by the Defense Department in 2015 and despite much opposition, it was finally approved by the FDA in 2018. Six months after the approval, an FBI intelligence bulletin marked “for official use only,” warned that the new drug would worsen the nation’s opioid epidemic. As efforts have focused on cracking down on opioid abuse and limiting production over the past years, hospitals are now seeing shortages of some opioids needed to intubate patients affected by COVID-19. Despite the initial setbacks on approving the drug, some now call it a life saver in a time that patients are in need of effective pain management.

What is Dsuvia?

Dsuvia is the brand name for the pill form of the synthetic opioid, sufentanil.  It’s only available in a single dosage as a small pill meant to dissolve under the tongue. Due to its potency, Dsuvia is only meant to be administered by a healthcare provider in a medically supervised setting. It is considered 5 to 10 times stronger than fentanyl, a drug that is associated with many overdose deaths, and 500 to 1,000 times more powerful than morphine. The development and approval of Dsuvia are in large part the result of interest from the Department of Defense, which initially funded the drug. Dsuvia is the result of years of collaboration between the creators and the Pentagon.

Timeline

2003

• Chester “Trip” Buckenmaier III, a specialist in acute pain management traveled to Iraq to help treat victims of bombs. While there, he realized the battlefield treatments were antiquated and not very effective in blocking pain. He became interested in finding better alternatives for soldiers.
• Military experts decided to try out fentanyl lollipops on soldiers and found them to be effective battlefield pain relievers.

2004

• The Pentagon’s Committee on Tactical Combat Casualty Care, which sets guidelines for battlefield medicine for the entire military, recommended the use of fentanyl lollipops “off label” – meaning they could essentially be used on the battlefield. The lollipops are portable, easy to use, and better at relieving pain than morphine shots. Although it was a better option, the dosing was imprecise and so Buckenmaier continued to look for better solutions.
• As the military searched for better treatment options, hospitals were seeing a large number of accidental overdoses due to mistakes dosing injectable opioids.

2005

• In a search for a safer alternative to injectable opioids, Dr. Pamela Palmer co-founded AcelRx and began the development of sufentanil, which could be delivered in pill form and less likely to trigger an accidental overdose.

2009

• Palmer and Buckenmaier met in New Orleans during a conference of the American Society of Anesthesiologists, where they discussed sudentanil’s potential use in the military. It was believed that a powerful drug that could be administered orally would be easier to administer on the battlefield than IV morphine. Buckenmaier liked the idea of using sufentanil but believed there was a need for a stronger drug.

2011

• Palmer’s company, AcelRx, received an initial $5.6 million contract from the Defense Department through Army Medical Research and Development Command’s Clinical and Rehabilitative Medicine Research Program.
• Later that year, the CDC issued a critical press release declaring a prescription painkiller overdose epidemic.

2012

• Military medical leaders recommended that Ketamine be used more often on soldiers. Unlike narcotic opioids, Ketamine does not slow breathing or lower blood pressure. It is also relatively inexpensive and easy for medics to carry, making it an ideal battlefield drug.

2014

• Military trauma specialists issued a set of guidelines stating that fentanyl lollipops should be given to soldiers who were not in shock, but medics should otherwise rely on ketamine, which is ideal for patients who are losing a lot of blood.
• At the same time, the Defense Department continued to invest in Dsuvia.
• The Committee on Tactical Combat Casualty Care and the Pentagon’s Joint Trauma System request studies to determine the necessity of investing in a new drug. A study on determining how Dsuvia compared with fentanyl lollipops and studies on ketamine auto-injectors were requested but did not occur.

2015

• The Defense Department awarded an additional $17 million to AcelRx to continue developing Dsuvia and help pay for stage 3 trials, which are designed to test the effectiveness of the drug.

2017

• AcelRx’s application for FDA-approval was accepted for review.
• Due to the drug’s small size, it was easily dropped during clinical trials, making it potentially dangerous if picked up and ingested on accident. For this reason, the FDA rejected Dsuvia by stating their safety concerns.

2018

• Along with support from the Pentagon, AcelRx reapplied for approval, conducted additional clinical trials, and amended the directions for use to make them clearer and enhance safety.
• The FDA approves Dsuvia after receiving a recommendation from the advisory committee on analgesics and anesthetic drug products. The committee had voted for its recommendation despite the absence of key committee members during the meeting.
• According to the CDC, about 68,000 Americans died of drug overdoses this year.

2019

• In an intelligence bulletin marked “for official use only,” the FBI warned that this new painkilling drug, Dsuvia, would likely exacerbate the nation’s opioid crisis. The bulletin also states that, “because of its potency, Dsuvia likely will cause deaths at a rate surpassing that associated with fentanyl, increasing the overall opioid-related death rate in the near term.”
• AcelRx begins to focus their efforts on the civilian market and target several ambulatory surgery centers as well as hospitals.

2020

• The Drug Enforcement Agency and FDA continue to monitor trends of diversion or misuse of Dsuvia. So far, there is very limited evidence that the drug is being diverted or misused.
• Opioid shortages brought on by the coronavirus pandemic have prompted renewed interest in Dsuvia.

The development and approval of Dsuvia may be considered essential by those who believe it has the potential to save lives, especially during the current pandemic. Despite the increase in illicit opioid use in the recent years, hospitals are experiencing a shortage in the drugs necessary to intubate patients affected by COVID-19.  The creators of Dsuvia believe the drug, which was initially created for use on the battlefield, can be just as effective in treating hospital patients.