Vertex’s non-opioid painkiller gets FDA priority review date
New England Council member, Vertex, has developed a new drug, suzetrigine, a non-opioid experimental painkiller that has been given priority review by the U.S. Food and Drug Administration.
The FDA set a Prescription Drug User Fee Act (PDUFA) date of January 30, 2025, meaning that it intends to decide about the medication on or before that date. Suzetrigine is a medication that targets certain sodium channels and thereby prevents pain signals from going to the brain. In January 2024, Vertex said the drug did not show any serious side effects and would seek broad approval for treating moderate-to-severe acute pain, which impacts over 80 million people in the U.S. per year.
“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,” said Vertex executive VP and chief regulatory and quality officer Nia Tatsis in the company’s announcement.
The New England Council commends Vertex for its commitment to targeting acute pain in this innovative manner.
Read more in the Boston Business Journal.