Will the FDA Approve New Opioid That is Stronger Than Fentanyl?

Opioid abuse has become quite the epidemic in the United States, but it is also a complicated issue to solve.  After all, opioids are not just a street narcotic: they are the basis of powerful pain-killing medications used in hospitals, operating rooms, and given as prescriptions for home use to patients as well.  Unfortunately, medically-based opioids are not necessarily any safer than the stuff you can find on the street; they are just better regulated. Still, there is always a chance for abuse and addiction when dealing with such powerful drugs.

Regardless of the danger, though, pain relief is an important medication for many people, and because of that drug companies continue to develop new ones.  For example, the United States Food and Drug Administration is up for considering the approval of a new drug called Dsuvia.  This is a new, single-dose tablet consisting of sufentanil, which is a synthetic opioid that is several times more potent than fentanyl and roughly 500 times more potent than morphine.  This little tablet comes with a dispenser: a preloaded plastic applicator that a patient can use to deposit the medication under the tongue of a patient.

While this drug is still up for full approval, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) did, recently, recommend the drug for approval, at a rate of 10-3.  The final approval decision is expected by November 3. Of course, even though the FDA typically follows these recommendations, they are not obliged to do so.

And although the drug is very powerful—which might be helpful in some cases—critics continue to express their concern over, for one, its immense strength. In addition, though, the product’s design makes it easier for a person who does not have the prescription to obtain the product.  Of course, it may also bear the potential for side effects such as restlessness, chest pain, muscle spasms, and fast heartbeat.

For one, University of Kentucky professor of anesthesiology Dr. Raeford Brown comments, “This drug offers no advance, in my mind, over previously available opioid formulations, but provides a great risk of harm to patients and the general public health.”

Dr. Brown also happens to be the chair of the FDA’s AADPAC.

He goes on to say, “I just don’t believe at this point in the US that there is any good reason to put another potent opioid on the streets.”

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