FDA Decision on Vertex’s Non-Opioid Analgesic Suzetrigine Due Early Next Year

1. FDA Decision Timeline: The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025, for Vertex's new drug application (NDA) for suzetrigine, a non-opioid pain treatment.
2. Priority Review: The FDA has granted suzetrigine priority review, which shortens the regulatory review period to six months.
3. Acute Pain Treatment: Suzetrigine is an investigational oral non-opioid treatment for moderate-to-severe acute pain, aiming to provide effective pain relief without the risks and addictive potential of opioids.
4. Phase III Trials: Suzetrigine demonstrated positive results in two Phase III trials, showing significant improvements in pain intensity in patients undergoing abdominoplasty and bunionectomies.
5. Market Potential: Suzetrigine is estimated to reach blockbuster status by 2029 and achieve $1.4 billion in sales by 2030, according to GlobalData's Pharma Intelligence Centre.
6. Global Pain Management Market: The global pain management market, including acute pain, is projected to reach approximately $115 billion by 2032.