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Unprecedented FDA Reversal: The Search Is On For Opioid Replacements

The Food and Drug Administration (FDA) is making an unusual move by ordering a drug manufacturer to pull a painkiller from the shelves. This is the first time the FDA is making this call in hopes of minimizing the nation’s terrifying opioid crisis. 

The administration ordered drug company, Endo, to remove the extended release drug, Opana ER, from pharmacies due to people misusing and abusing the drug. However, the company is pushing back but the FDA is threatening to withdraw its approval if the drug is not voluntarily pulled from the market. 

The unprecedented decision stems from the opioid crisis killing thousands of Americans. According to the Centers for Disease Control and Prevention (CDC), mortality rates were at a decline in 1990 but have now significantly increased since 2010 when prescription drug abuse became the new problematic wave. 

While most media covers the issue as it concerns young, poor, white Americans, the crisis has impacted all demographics in the U.S since 2010. According to the CDC, statistics show deaths among African Americans have increased by four percent, and deaths among Hispanics have increased by seven percent. Mortality rate has increased by 18 percent among the Native American population, which is a higher rate than the 16 percent increase in white Americans. Asian Americans have also seen an increase, although it is a slight increase compared to other populations, they have seen a three percent increase. 

In other words, the crisis has witnessed a statistical jump in mortality rates that shadow the number of deaths during the 1980’s and 1990’s when HIV and the crack-cocaine epidemic consumed US communities. 

So with the pull from one pain killer from pharmacy shelves, what could be a safer alternative? Well, there is a new potential drug on the rise that could be the alternative America is desperately needing. 

Pharmaceutical company, Vertex, has presented new data for an experimental drug that reduces acute pain, raising the chance of an alternative to addictive opioids.

In a press release, Vertex announced two studies showing the new drug, VX-548, has a “clinically meaningful reduction” in pain lasting more than a 48-hour period, compared to the placebo. Researchers evaluated people who recently had undergone surgery and in need of medication to treat “acute pain.”

Vertex described the new drugs as “safe and well tolerated” in part of the study conclusion. Although the results have not yet been vetted as part of the normal scientific review process. Vertex states that they will be applying for FDA approval mid 2024 to use the drug to treat “moderate to severe acute pain.” 

For decades, researchers have been looking for alternative medication to treat pain without the use of opiate-based painkillers. Common opiate-based painkillers include oxycodone, hydrocodone, and morphine. Although opioids’ medical purpose to treat pain works well, its consumption often carries risk of addiction. Fentanyl, a synthetic opioid, is also used to treat severe pain. However, it is more powerfully addictive than the average painkiller.

VX-548 is an oral medication that blocks pain signals in the peripheral nervous system, the areas outside the brain and spinal cord without being addictive. This makes the medication unique compared to opiate-based painkillers. VX-548 acts on the brain and spinal cord, whereas opioid painkillers activate an area of nerve cells in the brain and body called opioid receptors that block pain signals between the brain and the body. 

Researchers are hopeful that the drug will not carry the risk of addiction and if studies continue to be successful, the drug will be approved for treating pain. 

With the removal of Endo and the potential FDA approval and replacement of VX-548, America may be one avenue closer into capping the opioid crisis along with its mortality rates through safer prescription drugs.