The FDA Approved Sublingual Fentanyl Analogues as Alternative Opioids

Op-Ed: Fentanyl pill producers used to mimic other pharmaceuticals, now they don’t have to

For decades, the pharmaceutical industry has tried to develop opioids like OxyContin and Vicodin for chronic use, but they have failed. A new class of synthetic opioids, however, does work, and they are more potent and longer-acting.

The new class of opioids are called fentanyl analogs and they are about half the potency of morphine. They are produced in the Czech Republic and sold in Germany and other European countries (except the UK, where they are illegal).

The use of fentanyl analogs as replacement opioids for people who are hooked on OxyContin and Vicodin has exploded in the last few years. They are also used by drug cartels to create a new wave of “legal” drugs that are cheaper than the real thing.

According to the New York Times: “The price for the fentanyl analogs in the black market was about half — $3,500 — of the price of the real pills.”

There’s no evidence that fentanyl was ever abused by patients. But as more and more people are being overdosed by legal opioid tablets like OxyContin, the risk of accidental overdose increased. So in 2013, the FDA approved a new class of opioid medications that are not controlled substances. If they worked as well as the fentanyl analogs, they would now be the new gold standard of pain relievers.

The FDA approved these drugs as a treatment for moderate to severe pain that does not respond to opioids like OxyContin and Vicodin. The new opioids, called sublingual fentanyl-based therapies, are the first generation of newer opioid medications.

By the FDA’s definition, these medications “should have an analgesic effect on all patients with pain who fail to respond to opioids, regardless of the amount of dosage to achieve the effect.”

There were few clinical trials done in this development, with the FDA approving these new opioids by a vote of 7 to 4, rather than by a committee with input from the industry, patients and physicians.

FDA’s approval of these new opioids has been delayed for several years because of an increase in the number of deaths after the approval, and because of the stigma attached

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