aspirin/omeprazole / Generic mfg. - LARVOL DELTA

A Review of the Potential Roles of Antioxidant and Anti-Inflammatory Pharmacological Approaches for the Management of Mild-to-Moderate Symptomatic COVID-19. (PubMed, Med Sci Monit) - "Understanding the molecular mechanisms of SARS-CoV-2 infection is extremely important for the development of effective therapies against COVID-19. This review outlines the key pathways involved in the host response to SARS-CoV-2 infection and discusses the potential role of antioxidant and anti-inflammatory pharmacological approaches for the management of early mild-to-moderate COVID-19, using the examples of combined indomethacin, low-dose aspirin, omeprazole, hesperidin, quercetin, and vitamin C. The pharmacological targets of these substances are described here for their possible synergism in counteracting SARS-CoV-2 replication and progression of the infection from the upper respiratory airways to the blood, avoiding vascular complications and cytokine and bradykinin storms."

Clinical • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Retrospective Study of Outcomes and Hospitalization Rates of Patients in Italy with a Confirmed Diagnosis of Early COVID-19 and Treated at Home Within 3 Days or After 3 Days of Symptom Onset with Prescribed and Non-Prescribed Treatments Between November 2020 and August 2021. (PubMed, Med Sci Monit) - "Treatments consisted of indomethacin, low-dose aspirin, omeprazole, and a flavonoid-based food supplement, plus azithromycin, low-molecular-weight heparin, and betamethasone as needed. The main factor determining the duration of symptoms and the risk of hospitalization was the delay in starting therapy (P<0.001). CONCLUSIONS This real-world study of patients in the community showed that early diagnosis and early supportive patient management reduced the severity of COVID-19 and reduced the rate of hospitalization."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Intragastric acidity and omeprazole exposure during dosing with either PA32540 (enteric-coated aspirin 325 mg + immediate-release omeprazole 40 mg) or enteric-coated aspirin 325 mg + enteric-coated omeprazole 40 mg - A randomised, phase 1, crossover study (Aliment Pharmacol Ther) - P1, N=26; NCT00632086; Sponsor: Pozen; PMID: 23692061; "Total exposure to omeprazole from PA32540 was 57% of that from EC-omeprazole for the same dose amount (40 mg), while absolute difference in 24-h acid control was 7%. Omeprazole exposure and pH control with PA32540 appear similar to EC-omeprazole 20 mg."

P1 data • Acute Coronary Syndrome

Pozen: ROTH Conference (Pozen) - Anticipated NDA submission for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers by April 2013; Anticipated commercial partnership in US in 2013

Anticipated licensing / partnership • Anticipated NDA • Acute Coronary Syndrome

Pozen announces FDA acceptance of filing of New Drug Application for PA32540/PA8140 tablets (Pozen) - "POZEN...announced that the U.S. Food and Drug Administration...has accepted for review, the New Drug Application...for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA also indicated the review classification is Standard; therefore, the user fee goal date is January 24, 2014."

NDA • Acute Coronary Syndrome

Pozen: ROTH Conference (Pozen) - Anticipated patent expiry in US for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers on Feb 28, 2023; Anticipated patent protection for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers through 2032

Anticipated patent • Anticipated patent expiry • Acute Coronary Syndrome

Sanofi US and Pozen sign exclusive license agreement for the commercialization of PA8140/PA32540 tablets in the U.S. (Pozen Press Release) - "Sanofi...and POZEN Inc....announced the signing of an exclusive license agreement for the commercialization of POZEN’s proprietary, investigational, coordinated-delivery tablets combining immediate-release omeprazole, a proton pump inhibitor (PPI), and enteric-coated (EC) aspirin in a single tablet (“PA”), PA8140 and PA32540....POZEN will receive an upfront payment of $15MM and will be eligible for pre-commercial milestone payments of up to $20MM and other future milestone payments and royalties on product sales."

Commercial • Licensing / partnership • Acute Coronary Syndrome

Pozen: ROTH Conference (Pozen) - "Significant Reduction of Gastric Ulcers, Gastro-duodenal Ulcers and Discontinuations with PA32540 at 6 months"; "PA32540: Positive Top-Line Results from Two Pivotal Phase 3 Studies"; "Primary endpoint met: Cumulative observed incidence of gastric ulcers over six months"; "Key secondary endpoints met: Cumulative incidence of gastric and duodenal ulcers, Discontinuation due to pre-specified UGI adverse events, Heartburn resolution"; "Completed long-term safety study: (N=379) with no unexpected findings, and AEs consistent with the population and known profiles of ASA and omeprazole"

P3 data: top line • Acute Coronary Syndrome

Pozen submits New Drug Application for PA32540/PA8140 (Pozen) - "POZEN Inc...announced the submission of a New Drug Application...to the U.S. Food and Drug Administration...for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole...layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers."

NDA • Acute Coronary Syndrome