The U.S. Food and Drug Administration(FDA) approved a novel non-opioid drug named suzetrigine to treat moderate-to-severe pain. Unsplash
Medicine

FDA Approves New Non-Opioid Painkiller 'Suzetrigine'

FDA approves Suzetrigine, a non-opioid which blocks pain signals to the brain, making it a non-addictive pain drug

Jithin Paul

The U.S. Food and Drug Administration(FDA) approved a novel non-opioid drug named suzetrigine to treat moderate-to-severe pain. Unlike the opioid painkillers available on the market, suzetrigine does not become addictive. This pain medication, sold by Vertex Pharmaceuticals under the brand name Journavx, is the first ever non-opioid drug approved since the class was introduced in the 1980s.

The drug is receiving praise and appreciation from specialists as it reduces the chance of drug overdose, thereby becoming a safer alternative to opioids. Researchers hail it as the first of the many powerful non-addictive drugs for pain relief.

The drug is receiving praise and appreciation from specialists as it reduces the chance of drug overdose, thereby becoming a safer alternative to opioids.

How does suzetrigine works?

Being a non-opioid painkiller, the working principle of suzetrigine is quite different from that of opioids.

Suzetrigine acts as a painkiller by selectively blocking a sodium channel that is specific to pain-sensing nerve cells present in the whole body except the brain. [2] Moreover, it is not addictive as it does not bind to the opioid receptors of the central nervous system. Hence, it delivers opioid-level pain suppression without the risks of addiction, sedation or overdose. Sodium channels operate like gates, opening and closing in response to electrical signals flowing through nerve cells to let sodium ions pass through, which in turn initiates a series of nerve impulses that transmit pain signals to the brain. [1]

Suzetrigine acts as a painkiller by selectively blocking a sodium channel that is specific to pain-sensing nerve cells present in the whole body except the brain.

The major challenge faced by the researchers was to find the right sodium channel. It took years of research and the collective efforts of numerous scientists to pinpoint the exact channel. Once scientists found Nav 1.8 - a specific channel that selectively inhibits pain neurons, further clinical trials were conducted by Vertex Pharmaceuticals, making it a success.

How does Vertex test the efficacy of suzetrigine?

The drug was tested in two large clinical trials, each with approximately 1,000 patients who had severe pain from surgery. For one set of patients, the surgery is an abdominoplasty, or tummy tuck; for the other, a bunionectomy. All the 1000 patients were randomly administered with placebo, vicodin (a combination opioid) or suzetrigine. Both trials demonstrated a statistically significant superior reduction in pain with Journavx (suzetrigine) compared to placebo.

Apart from individuals with acute pain, people who are suffering from damaged nerve conditions and diabetes can also depend on suzetrigine for relief.

Drawbacks of suzetrigine:

Common downsides of suzetrigine include itching, rash, muscle spasms, and increased levels of creatine kinase. It also showed nausea, constipation and headache as side effects. Moreover, it was not better than drugs like hydrocodone/acetaminophen at relieving pain. However, the major problem was the cost of the pills. Patients are expected to take two pills a day, which cost around 31 dollars as of now.

References

1. Wang, Jun, Shao-Wu Ou, and Yun-Jie Wang. 2017. “Distribution and Function of Voltage-Gated Sodium Channels in the Nervous System.” Channels 11 (6): 534–54. https://doi.org/10.1080/19336950.2017.1380758. (Accessed on February 01, 2025)

2.  “FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain.” U.S. Food And Drug Administration, January 30, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain. (Accessed on February 02, 2025)

‌(Input from various sources)

(Rehash/Jithin Paul/SSK)

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