Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a …
Jan 30, 2025 · BOSTON--(BUSINESS WIRE)--Jan. 30, 2025-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to …
FDA Approves Novel Non-Opioid Treatment for Moderate to …
Jan 30, 2025 · The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, ... The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated. ### Boilerplate. The FDA, an agency within the U ...
FDA approves painkiller designed to eliminate risks of addiction ...
Jan 30, 2025 · The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often follows surgery or injuries. It’s the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen.
Vertex Announces FDA Acceptance of New Drug Application for …
Jul 30, 2024 · Suzetrigine has the potential to be the first new class of medicine to treat acute pain in over twenty years. The FDA has granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025.
FDA Approves Journavx Drug to Treat Pain Without Addiction …
Jan 30, 2025 · The drug, Journavx by Vertex Pharmaceuticals, blocks pain signals to the brain, making it nonaddictive. ... To test the drug, Vertex, which is based in Boston, conducted two large clinical trials ...
FDA approves Vertex Pharmaceuticals' Journavx for acute pain
Jan 31, 2025 · The US Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ oral Journavx (suzetrigine) to treat adults with acute pain. ... Vertex Pharmaceuticals president and CEO Reshma Kewalramani stated: “With the approval of Journavx, a non-opioid, pain signal inhibitor and the first new class of …
FDA Approves Vertex’s Journavx as First New Pain Drug in Decades
Jan 30, 2025 · A week after Purdue Pharma and the Sackler family agreed to pay $7.4 billion to settle lawsuits stemming from the company’s opioid-based painkiller OxyContin, the FDA approved Vertex’s suzetrigine as the first new mechanism for acute pain in more than 20 years—possibly turning a new page in this treatment space.. Suzetrigine—to be marketed as Journavx—is a first-in-class non-opioid ...
FDA Approves Vertex Pharma's JOURNAVX As The First Drug In …
Jan 31, 2025 · (RTTNews) - Vertex Pharmaceuticals Inc. (VRTX) has secured FDA approval for Suzetrigine, an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor, for the treatment of adults with ...
Vertex Announces FDA Acceptance of New Drug Application for …
Jul 2, 2024 · Investigational vanzacaftor/tezacaftor/deutivacaftor was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of cystic fibrosis. The vanza triple will be subject to a meaningfully lower single-digit royalty obligation, compared to the rate payable on Vertex’s current CF portfolio.
Vertex’s non-opioid pain drug gets FDA approval in milestone for ...
Jan 30, 2025 · The movement to steer pain treatment away from opioids notched a major victory Thursday, as the Food and Drug Administration approved a new, highly anticipated drug from Vertex Pharmaceuticals.. The culmination of decades of work, Vertex’s Journavx is now cleared to treat the short-lived “acute” pain usually felt after an accident or a surgery.
- Some results have been removed