The Office for Sanitary Supervision of the Quality of Food and Medicines of the USA (FDA) has approved a new type of analgesic drug for the first time in 25 years. The medication, known as suzetrigine and produced under the Journavx brand, is designed to treat moderate and severe acute pain. Administered twice daily in the form of 50 mg tablets.
Clinical trials have demonstrated that Suzetrigine is as effective in reducing pain as opioid analgesics, without causing addiction. This makes the drug a potentially important alternative in addressing the opioid crisis, which claims over 100,000 lives annually in the United States.
Suzetrigine works by blocking sodium ion channels in nerve cells, thereby preventing the transmission of pain signals to the brain. Despite decades of drug development in this area facing setbacks, Vertex has successfully brought this drug to fruition.
The FDA’s approval is based on the results of two Phase III clinical trials conducted among patients recovering from abdominoplasty surgery and foot bone removal. Approximately 1,000 participants were given Suzetrigine, a placebo, or a combination of hydrocodone with acetaminophen for comparison. Suzetrigine demonstrated comparable efficacy to the opioid analgesic, with quicker action and fewer side effects.
Prior to Suzetrigine, patients seeking pain relief had the choice between over-the-counter drugs like Ibuprofen and Acetaminophen, or opioids with the associated risk of dependence. The approval of Suzetrigine now offers a third option for effective pain relief without the risk of dependence on the brain and spinal cord.
Currently, Suzetrigine is only approved for treating acute pain, but Vertex has conducted successful efficacy tests for chronic pain caused by diabetic neuropathy, with Phase III clinical trials ongoing. Other pharmaceutical companies are also developing similar drugs that target sodium channels.
Side effects of Suzetrigine include itching, muscle cramps, elevated creatinkinase levels in the blood, and rashes. The drug is incompatible with medications that suppress the CYP3A enzyme (including certain antibiotics and antivirals) and grapefruit consumption.
Vertex has announced that the cost of 50 mg tablets will be $15.50 each, totaling approximately $30 per day for treatment – considerably more expensive than the hydrocodone and acetaminophen combination at $7 per day. Coverage by insurance