FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults.
It reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.
The first drug to be approved in this new class of pain management medicines.
It is 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.
This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”
In two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.
Participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication.
Both trials demonstrated a statistically significant superior reduction in pain with suzetrigine compared to placebo.
The most common adverse reactions in study participants who received suzetrigine were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
It is contraindicated for concomitant use with strong CYP3A inhibitors.
Additionally, patients should avoid food or drink containing grapefruit when taking this drug.