U.S. Approves a New Non-Opioid Painkiller for the First Time in Decades

The new drug explores an untapped avenue in pain management.

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Pablo Martínez-Juarez

Writer
pablo-martinez

Pablo Martínez-Juarez

Writer

Environmental economist and science journalist. For a few years, I worked as a researcher on the economics of climate change adaptation. Now I write about that and much more. LinkedIn

94 publications by Pablo Martínez-Juarez

Painkillers are among the most commonly used drugs in the world. However, these pain-relieving medications can also have a darker side, especially in the U.S., which is currently facing an opioid addiction epidemic.

FDA-approved. The Food and Drug Administration announced on Thursday the approval of a new medication. This non-opioid analgesic marks the first entry of this category into the U.S. market in decades.

According to the FDA’s press release, the new drug is designed to treat moderate to severe acute pain in adult patients. Notably, the agency highlights that patients on this treatment should avoid consuming grapefruit, which is a common recommendation for certain medications.

Jacqueline Corrigan-Curay, director of the FDA’s Center for Drug Evaluation and Research, said in the press release, “Today’s approval is an important public health milestone in acute pain management. A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”

Suzetrigine. Vertex Pharmaceuticals developed the new drug suzetrigine, which will be sold in 50 mg oral tablets under the brand name Journavx.

The medication is administered in several doses: An initial dose of 100 mg followed by 50 mg every 12 hours. This is based on findings from clinical trials that led to its approval. These trials indicated that while suzetrigine is an effective compound, it provides a moderate pain-reducing effect.

“It’s not a slam dunk on effectiveness,” Michael Schuh of Mayo Clinic, a pain medicine expert who wasn’t involved in the drug’s development, told AP. He added, “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot of promise.”

How does it know where to alleviate pain? Suzetrigine operates by targeting sodium channels in the peripheral nervous system, which are involved in pain signaling. This mechanism differs from that of other analgesics, such as opioids, which act on the brain regions that process pain. Instead, suzetrigine blocks the pain signals from reaching the brain.

More than 25 years later. CNN reports that this is the first analgesic approved by the FDA since 1998. That year, the FDA approved Celebrex (celecoxib), a non-steroidal anti-inflammatory drug that inhibits Cox-2. This enzyme accelerates the formation of substances that cause inflammation and pain in the body.

Investor interest. Indications suggest that this announcement could lead to a recovery in the market value of Vertex Pharmaceuticals following poor interim results at the end of last year. The company’s stock price gradually rebounded throughout January, and the recent announcement may confirm its stock market performance is going “back to normal.”

An epidemic. Painkillers are the most commonly prescribed type of medication in hospitals in the U.S., with opioids accounting for nearly half of all pain medication prescriptions. The opioid epidemic is a complex issue driven by many factors, particularly the rise of fentanyl. While approved for medical use, this synthetic opioid has serious consequences when misused as a recreational drug.

The new analgesic works through different mechanisms than opioids and doesn’t produce feelings of euphoria or excitement. As such, experts believe it’s unlikely to lead to dependence or addiction. This could be a crucial step in mitigating the current crisis, especially considering that many cases of opioid dependence began with medically prescribed use.

Image | Towfiqu barbhuiya

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