Articles related to FDA

As the optometry field advances, newer, more innovative medications are being introduced for the management of dry eye disease and Demodex blepharitis. These developments pave the way for more personalized and successful patient care.

FDA Cautions Against Hidden Drug Ingredients in Joint Pain Supplements In response to recent findings, the FDA warns of significant health risks associated with three specific dietary supplements marketed for joint pain and rheumatoid arthritis relief due to the discovery of unlisted active pharmaceutical ingredients.

Opvee Reverses Remifentail-induced Respiratory Depression Within 5 Minutes As the opioid crisis continues to evolve, so too does your arsenal of interventions. The FDA’s recent approval of Opvee, a nalmefene-based nasal spray, introduces a new tool for physicians in the fight against opioid overdose.

The SSRI inhibitor was previously limited to adults. As physicians, we are continually seeking effective treatment options for our pediatric patients. The recent FDA approval of Lexapro for pediatric GAD treatment marks a significant advancement in this field.

Unveiling a new path in osteoarthritis pain management, the FDA’s Breakthrough Therapy designation for resiniferatoxin marks a promising development. The FDA has granted Breakthrough Therapy designation to resiniferatoxin for treating osteoarthritis knee pain. Extracted from a cactus-like plant, resiniferatoxin, a potent TRPV1 agonist, boasts similarities to capsaicin. Notably, its potency sets it apart. Resiniferatoxin is administered through intra-articular injection, promoting pain relief by temporarily disabling TRPV1-expressing nociceptors. This unique mechanism targets one of the most profound symptoms of osteoarthritis: pain. Its potential benefits are eagerly awaited by millions of patients struggling with this relentless disease. Stepping up to the challenge, Grünenthal, the company behind resiniferatoxin, is launching a global Phase 3 program. They aim to enroll more than 1,800 patients with knee osteoarthritis who haven’t found sufficient relief from existing non-surgical treatments. With a focus on improved pain and physical function scores according to the WOMAC osteoarthritis index, the program’s efficacy endpoints are set for up to 52 weeks. Turning the tide in osteoarthritis treatment, the Breakthrough Therapy Designation offers an expedited path for this non-opioid therapy option. As Grünenthal’s Chief Scientific Officer, Jan Adams, optimistically noted, it is hoped that this designation will speed up resiniferatoxin’s availability to patients.

Dive into the implications of the FDA’s approval of nirmatrelvir+ritonavir, the first oral antiviral pill for COVID-19. The FDA’s recent approval of nirmatrelvir+ritonavir (Paxlovid, Pfizer) marks a significant advancement in COVID-19 treatment. This oral antiviral, the first of its kind, targets mild to moderate cases in high-risk adults. It’s the fourth drug, but the first pill, to gain FDA approval for treating adult COVID-19 patients. Nirmatrelvir+ritonavir will remain available under emergency use authorization, ensuring continued access for adults and for eligible 12-18 year olds. However, it’s not approved for pre- or post-exposure COVID-19 prevention. Patrizia Cavazzoni, MD, the director for the FDA’s Center for Drug Evaluation and Research, applauded the drug’s approval. She stressed the agency’s commitment to advancing new prevention and treatment options. The efficacy of nirmatrelvir+ritonavir comes primarily from the EPIC-HR clinical trial. This trial studied nonhospitalized symptomatic adults diagnosed with SARS-CoV-2 infection. In the study, nirmatrelvir+ritonavir reduced COVID-19–related hospitalizations or deaths by 86% compared to placebo when used within five days of symptom onset. Almost equal numbers of patients received nirmatrelvir+ritonavir and a placebo. Only 0.9% of the combo pill group were hospitalized or died within 28 days of follow-up, compared to 6.5% in the placebo group. […]