By Pat Anson

The Food and Drug Administration could approve an experimental non-opioid analgesic early next year, potentially making it the first new medication for acute pain in over two decades.

Vertex Pharmaceuticals says the FDA has accepted its New Drug Application for suzetrigine, giving the drug a priority review with a target action date of January 30, 2025. Suzetrigine has previously been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients,” Nia Tatsis, PhD, an Executive Vice President and Chief Regulatory and Quality Officer for Vertex, said in a statement.

“The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

Suzetrigine is designed to block pain in the peripheral nervous system, rather than the brain. That means it won’t have the “liking” effects of opioids or be as addictive.  

In Phase 3 clinical studies, suzetrigine was more effective in reducing post-operative pain than a placebo after minimally invasive surgeries.  Over 80% of patients rated suzetrigine as good or excellent in treating acute pain, but it was not more effective than a combination of the opioid hydrocodone and acetaminophen, more commonly known as Vicodin.

Vertex hopes suzetrigine will eventually be approved for a variety of pain conditions, not just post-operative pain.  The company has been studying the drug as a treatment for pain caused by diabetic peripheral neuropathy.

“In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, MD, a Vertex consultant and Associate Professor of Emergency Medicine at Harvard Medical School.

The Biden Administration has been under pressure from lobbyists, politicians and anti-opioid activists to have the FDA approve more non-opioid medications like suzetrigine. The new analgesics are expected to be far more expensive than opioids and other older pain relievers.

If the FDA approves suzetrigine in January, it will coincide with implementation of the NOPAIN Act, which will expand access to non-opioid analgesics in outpatient surgical settings by making them eligible for higher Medicare reimbursement rates.