Combination of aspirin and omeprazole approved
Yosprala, the only once-daily prescription fixed-dose combination of aspirin and the proton-pump inhibitor omeprazole, has been approved by the FDA. The product is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk for developing aspirin-associated gastric ulcers.
Yosprala uses the Aralez Pharmaceuticals' proprietary Intelli-COAT system, which is formulated to sequentially deliver immediate-release omeprazole (40 mg) followed by a delayed release, enteric-coated aspirin core in either 81 mg or 325 mg doses. The FDA's approval was based on the results of randomized, double-blind controlled clinical trials in which patients were randomly assigned to receive either Yosprala 325 mg/40 mg or enteric-coated aspirin 325 mg.
Each study achieved its individual primary end point, with patients taking Yosprala experiencing significantly fewer endoscopic gastric ulcers compared with those taking enteric-coated aspirin alone. Significantly fewer Yosprala-treated patients discontinued therapy compared with patients taking enteric-coated aspirin. The most common adverse reactions reported are gastritis, nausea, diarrhea, gastric polyps, and noncardiac chest pain.
FDA approves new quadrivalent influenza vaccine
Protein Sciences Corporation's quadrivalent formulation of Flublok influenza vaccine was approved by the FDA to protect against four strains of influenza: three of the same strains found in trivalent Flublok plus an additional B strain.
The vaccine is approved for adults age 18 and older and will be available in prefilled syringes in 2017. Flublok Quadrivalent is the first and only high-antigen-content quadrivalent flu vaccine approved by the FDA. According to the manufacturer, it contains three times more active ingredient than all other quadrivalent vaccines, making it a good choice for older adults and those with compromised immune systems.
In a clinical study of 9,000 adults age 50 and older, those who received Flublok Quadrivalent were over 40% less likely to get cell-culture-confirmed influenza than those who received a leading egg-produced quadrivalent flu vaccine. Flublok contains pure protein made without infectious influenza virus, antibiotics, eggs, thimerosal, preservatives, gelatin, or latex.
Zinplava approved to reduce recurrence of C. difficile infection
The FDA approved Merck's bezlotoxumab injection (Zinplava) to reduce the recurrence of Clostridium difficile infection (CDI) in patients age 18 and older who are at high risk for CDI recurrence. Bezlotoxumab is a monoclonal antibody indicated for adults who are taking an antibiotic for CDI and are at risk for becoming infected again. The new medication is not an antibiotic; rather, it binds to and neutralizes toxin B, which is produced by C. difficile and is central to its virulence. The medication is administered as an I.V. infusion over 1 hour and is to be taken only in conjunction with antibacterial drug treatment of CDI.
In clinical trials of bezlotoxumab, nausea, fever, and headache were among the most common adverse reactions reported on the day of infusion or the following day. Heart failure was cited as a serious adverse reaction but occurred primarily in patients with underlying heart failure (HF). Bezlotoxumab should be reserved for use in patients with a history of HF when the benefits of use outweigh the risk. In addition, there is a potential for immunogenicity after administration.