CV Therapeutics ranolazine
This article was originally published in Pharmaceutical Approvals Monthly
Each of three dose levels of sustained-release ranolazine "was associated with statistically significant (p<0.005) increases in patients' treadmill exercise duration with no clinically meaningful effects on blood pressure or heart rate compared to placebo" in a pivotal trial, the company reported at the 49th annual meeting of the American College of Cardiology. The multicenter, double-blind MARISA (Monotherapy Assessment of Ranolazine In Stable Angina) study randomized 191 patients withdrawn from other anti-anginal drugs to 500 mg, 1000 mg, or 1500 mg ranolazine b.i.d. or placebo for a four-period study. Patients received each of the treatments for a seven-day period in a Latin square crossover design. Exercise testing with a modified Bruce protocol programmed into treadmills was performed at trough (12 hours after dosing) and peak (four hours after dosing). Results for 175 patients who completed three or four of the treatment periods showed exercise duration at trough of 559 seconds for the 1500 mg dose, 545 seconds for 1000 mg and 533 seconds for 500 mg vs. 511 seconds for placebo (p<0.001, p<0.001 and p=0.003, respectively). Time to angina at trough was 472 seconds (1500 mg), 457 seconds (1000 mg) and 437 mg (500 mg) vs. 412 seconds for placebo (p<0.001, p<0.001 and p=0.005). A second pivotal trial, CARISA, will test the drug in combination with other anti-angina agents. Results are expected next year
You may also be interested in...
Amwell’s increased the size of its IPO and raised $742m when it sold 41.2 million shares at $18 each.
Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.