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Could this new painkiller put an end to the opioid crisis?

1/4/2025

Translation: Veronica Bielawski

For the first time in twenty years, a painkiller with a novel mechanism of action is entering the market. It promises strong pain relief without the addictiveness of opioids. Here’s how the drug works, whether it will be available in Europe and who it’s suitable for.

In January, the US Food and Drug Administration (FDA) approved suzetrigine, a painkiller with a new mechanism of action. What makes it so special is that it creates no risk of addiction – a decisive advantage over opioids, which are often prescribed for severe pain. Although opioids effectively relieve pain, their mood-enhancing effects in the brain can quickly lead to addiction. The consequences are frightening in the USA. Every year, tens of thousands of people (article in German) die from an overdose of strong painkillers such as fentanyl.

How painkillers and opioids work

Conventional painkillers such as ibuprofen, which are used for mild to moderate pain, have no addictive potential. They work by inhibiting certain enzymes (link in German), namely cyclooxygenases, reducing the production of pro-inflammatory substances.

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If they’re not enough, opioids may be prescribed in Germany and Switzerland for severe pain, for example due to cancer or chronic illnesses. Opioids dock onto receptors in the central nervous system (link in German), blocking the transmission of pain and triggering euphoria. Repeated use quickly leads to tolerance and has a high potential for addiction.

Suzetrigine’s novel mechanism of action

Suzetrigine, on the other hand, acts directly on the nerve cells that transmit pain signals. To be precise, it blocks Nav1.8 sodium ion channels, which play a key role in the transmission of pain signals. In other words, suzetrigine interferes with the transmission of pain only, without affecting other bodily functions. This should allow for more effective pain relief with fewer side effects.

The critical difference to opioids is that suzetrigine doesn’t act on the central nervous system, avoiding the potential for addiction by acting exclusively in the peripheral nerve cells.

The approval of suzetrigine comes amid the devastating opioid crisis in the US, which claims thousands of lives each year. The FDA expedited the development and approval of suzetrigine. «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,» explained Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research.

Fentanyl is now the main driver of the opioid crisis in the US and is responsible for the majority of drug-related deaths.
Source: Statista 2025

When is suzetrigine coming to Europe?

Though suzetrigine has been approved in the USA, it’s not yet available on the European market. So far, no concrete information has been released on its approval in Europe. The drug approval process by the European Medicines Agency (EMA) can take several years.

However, the drug’s accelerated approval in the USA suggests that the responsible authorities are closely monitoring the development of suzetrigine and may also consider a faster approval process here.

Who could suzetrigine be suitable for?

Suzetrigine is currently approved in the USA for the treatment of moderate to severe acute pain. This includes pain after surgery or injury, for instance. The drug could also be beneficial to people with advanced tumour diseases.

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Side effects and precautions

As with any medication, there are a few things to bear in mind with suzetrigine. The most common side effects are itchiness, skin rashes and muscle cramps. Pregnant and breastfeeding women should consult their doctor before taking the medication. People with liver problems should also be careful and might need a lower dose.

A glimmer of hope on the horizon

Suzetrigine could mark a turning point in pain therapy. It offers the prospect of effective pain relief without the dreaded side effects of opioids. However, further research is still needed to understand the full potential and possible long-term side effects. Patients in Germany and Switzerland will have to wait a while longer.

Header image: MOLEQL/Shutterstock

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Anna Sandner

Senior Editor

Anna.Sandner@galaxus.de

Science editor and biologist. I love animals and am fascinated by plants, their abilities and everything you can do with them. That's why my favourite place is always the outdoors - somewhere in nature, preferably in my wild garden.

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