US FDA Approves New—and Very Potent—Painkiller, Despite Warnings

Against strong advice from physicians, the United States Food and Drug Administration has moved forward on approvals for a new—and extremely potent—opioid painkiller.  On October 12—so, not that long ago—AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.  The purpose, of course, was for the committee to determine the drug’s overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

Accordingly, then, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted in favor, 10 to 3, of approval of this medication.  As such, the FDA issued its approval at the end of the week.

What makes this particular approval so interesting is that the drug has many outspoken critics. The most notable of these critics might actually be in-house:  the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen.  And among his criticisms is the fact that the FDA actually skirted its standard vetting process for approval.

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated—and very unstable—opioid market. More importantly, though, some critics argue that the drug’s size (about 3mm wide) and potency (at least 10 times more powerful than fentanyl) will certainly have more appeal to those looking to misuse/abuse the drug or to sell it.

To that, however, anesthesiologist Dr. Pamela Palmer—who is also the co-founder of AcelRx—argues that “diversion” of Dsuvia is extremely low.  Diversion, of course, is the term used to describe how drugs end up in the hands of someone other than the intended patient.  Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg.  That is roughly one-millionth of a gram.  Also, Dr. Palmer argues that risk for abuse is low because it must be administered—again, by a health care professional in a controlled medical center setting—under the tongue.

Still, critics hold that the drug does not serve a unique need, despite its seemingly more controlled administration environment.

 

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