celecoxib (AI 525, CEP-33222) / Teva - LARVOL DELTA

Zydus' Non-Steroidal Painkiller Receives FDA Final Nod (The Economic Times) - "Zydus Lifesciences announced that its nonsteroidal anti-inflammatory drug (NSAID), Celecoxib, has received final approval from the U.S. Food and Drug Administration (FDA). Celecoxib is used to manage pain and inflammation associated with conditions like arthritis, ankylosing spondylitis, and menstrual pain."

ANDA • Pain

In the phase 3 CALGB/SWOG 80702 study, patients with ctDNA-positive stage III #ColonCancer achieved an estimated 5-year OS rate of 61.6% with adjuvant celecoxib/FOLFOX vs 39.9% with placebo. @GIcancerDoc @MayoCancerCare #CRCsm

Clinical

Can a COX-2 Inhibitor Boost Disease-free Survival in CRC? (MedPageToday) - P3, N=2,526; NCT01150045; "With a median 6 years of follow-up, the 3-year DFS rate was 76.3% in patients treated with the selective cyclooxygenase-2 (COX-2) inhibitor versus 73.4% in placebo-treated patients, translating to an HR for disease recurrence or death of 0.89 (95% CI 0.76-1.03, P=0.12), reported Jeffrey A. Meyerhardt, MD..."

Media quote • P3 data

NSAIDs Boost CV, Bleeding Risks in Post-MI Patients (TCTMD) - "Commenting for TCTMD, Deepak Bhatt, MD...said the study is a good reminder that NSAIDs are not benign medicines, particularly among patients taking antithrombotic therapy for a cardiovascular condition. 'I think many times doctors-and patients, of course, since these can be obtained over the counter-forget that there is a risk to NSAID use having to do with cardiovascular risks, but also bleeding risks, that sometimes are not appreciated.'"

Media quote

A survey of the administration of prednisolone versus ibuprofen analgesic protocols after ambulatory tonsillectomy. (PubMed) - "The administration of ibuprofen compared to prednisolone improves postoperative comfort in children undergoing ambulatory tonsillectomy without increasing the incidence of side effects."

Journal • Biosimilar • Pain

A phase II study of gemcitabine by fixed-dose rate infusion, cisplatin, and celecoxib in metastatic pancreatic cancer (J Clin Oncol) - P2, N=22; "Celecoxib can be safely administered in combination with gemcitabine and cisplatin. The regimen of gemcitabine by the fixed dose rate infusion and cisplatin was associated with significant myelosuppression. The addition of celecoxib to a regimen utilizing gemcitabine by fixed dose rate infusion did not appear to have a significant impact on the 6-month survival rate and overall survival. No significant financial relationships to disclose."

P2 data