Penwest drug fails to meet primary endpoint
Penwest Pharmaceuticals' pivotal efficacy trial of the low dose strength of PW2101, its beta blocker intended for the treatment of hypertension and angina did not meet the study's primary endpoint.
Penwest Pharmaceuticals' pivotal efficacy trial of the low dose strength of PW2101, its beta blocker intended for the treatment of hypertension and angina did not meet the study's primary endpoint.
The results, while positive, were not statistically significant at a p-value of 0.05. However, the low dose strength did meet some of the trial's key secondary endpoints.
The study, involving 110 hypertensive patients, was a randomised, double-blind, parallel-group study comparing PW2101 to placebo. The primary endpoint for the study was a change in the mean seated office cuff diastolic blood pressure (mmHg) from baseline to week six. Although in the trial the baseline-adjusted difference in reduction in diastolic blood pressure between the low dose strength of PW2101 and placebo was 2.4 mm Hg after six weeks, this difference was not statistically significant at a p = 0.05. However, the study did reach statistical significance for some of the key secondary endpoints including the measurement of the change in 24-hour mean ambulatory diastolic blood pressure from baseline to week six. In the first pivotal trial conducted on this low strength of PW2101, the drug demonstrated a statistically significant (at the p<0.05 level) reduction in exercise-induced heart rate in volunteers meeting the primary endpoint of the first trial.
Dr Thomas Sciascia, Penwest's chief medical officer, said: 'Although we did not meet the primary endpoint statistically in this study, we believe that based on the overall statistics found in both trials the low dose strength of PW2101 is clinically active. Accordingly, we intend to submit the data to the FDA in the first quarter of 2005 and expect to have discussions with the FDA on its approvability and labeling for the low dose of PW2101.'
The FDA has accepted for review the company's NDA for PW2101, which included the three higher strengths of this product, and Penwest is currently in discussions with potential partners for marketing PW2101 in the US. The company believes that the low dose strength represents approximately 15%-20% of the potential market opportunity for PW2101