Drugs

Vertex Non-Opioid New Pain Drug Approved

FDA has approved a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a groundbreaking move away from opioid pain drugs for treating moderate to severe acute pain in adults. The first-in-class drug offers a novel approach to pain relief by targeting sodium channels in the peripheral nervous system, preventing pain signals from reaching the brain, an agency release says.

Approval was based on data from two clinical trials involving patients undergoing surgery — one following abdominoplasty and the other following bunionectomy. Both studies demonstrated that Journavx provided significantly greater pain relief compared to a placebo, the agency says. Patients in the trials were allowed to use ibuprofen as needed for additional pain management

Regarding safety, the most common side effects reported included itching, muscle spasms, increased levels of creatine phosphokinase (a marker of muscle injury), and rash. The drug is contraindicated for use with strong CYP3A inhibitors, and patients are advised to avoid grapefruit products while taking it.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome