The controversial DSUVIA painkiller is poised to upend the opiate market. Reportedly, 500 times more potent than morphine, DSUVIA is formulated to dissolve instantly, allowing it to act more quickly than other opioids. It was recently approved by the FDA despite reservations.

Acelrx, the company behind DSUVIA, believes that this drug represents an “important non-invasive acute pain management option.” Others are somewhat skeptical of the new drug.

“I find it truly surprising that in the midst of this nation-wide opioid problem, a new product is being considered for release that appears to be the ideal formulation for abuse of a very high potency narcotic with very little obvious clinical indication,” said Christopher Creighton, M.D., Physician Partners of America pain specialist in Richardson, Texas. He weighed in a few days before the FDA’s decision on DSUVIA.

Last year, the FDA rejected the drug’s approval. There were concerns that the drug could be administered improperly if it wound up in the wrong hands. This year guidelines have been included that require the drug to be administered only by trained healthcare professionals.

In the midst of the current opioid epidemic, lawmakers have serious concerns about the potential for misuse. Sen. Edward Markey (D-Mass.) believes that the FDA’s consideration of this new drug “makes no sense.” In a statement, Markey noted, “Even in the midst of the worst drug crisis our nation has ever seen, the FDA once again is going out of its way to approve a new super-charged painkiller that would only worsen the opioid epidemic.”

Pain management expert  and Chief Medical Officer with Physician Partners of America Abraham Rivera, M.D. echoes these concerns. He points out that DSUVIA is not a new drug. “It’s actually an oral formulation of Sufentanil. This drug was invented in the late 1950’s… It’s a ‘cousin’ drug to Fentanyl, Alfentanyl, Remifentanil, Carfentanyl, and a few others.”

When asked about the effectiveness of the drug as a pain management treatment, Rivera readily admits that it is extremely potent. However, he goes on to say, “In my opinion, it brings very little to the armamentarium of a pain management practitioner. It has a serious potential for abuse and misuse.”

Physician Partners of America has long focused on interventional pain management techniques that do not rely on opioids as a primary course of treatment.

Like Senator Edward Markey and others in the healthcare and political arenas who have seen firsthand the devastating effects opioid addiction has had on the community, Drs. Creighton and Rivera worry that people who want to abuse DSUVIA painkiller will find creative ways to accomplish their goals — regardless of the safety precautions the medical community or pharmaceutical companies put in place.

This is especially worrisome considering the potency of the drug. Dr. Rivera states: “This particular drug packs such a punch that I am afraid the recreational street chemists will get their numbers wrong and write their mistakes on gravestones.”

Non-oral forms of the DSUVIA painkiller are already being used in the operating room as an adjuvant anesthetic. In this setting, it has excellent cardiovascular stability at high doses, Rivera says.

He summed up his feelings about introducing DSUVIA to the market like this: “Taking this drug out of the operating room and putting it in an oral formulation reminds me of the making of small nuclear weapons. In times of conflict, some people thought that it would be a good idea. Drop a small nuke here and there and save money on bullets. Good thing somebody disagreed.”