Penwest plans NDA for hypertension drug
Following the results of the pivotal efficacy study for PW2101, its product for the treatment of hypertension, Penwest Pharmaceuticals is planning to submit a New Drug Application (NDA) to the US FDA before the end of the year seeking approval for higher strengths of the product.
Following the results of the pivotal efficacy study for PW2101, its product for the treatment of hypertension, Penwest Pharmaceuticals is planning to submit a New Drug Application (NDA) to the US FDA before the end of the year seeking approval for higher strengths of the product.
The company says that the primary end points of the study were met, and the clinical development programme is now complete.
The pivotal study was a randomised, double-blind, parallel-group study comparing the PW2101 to placebo. A total of 164 subjects received at least one dose of study medication and were evaluated for safety. All the adverse events were mild and transient in nature, with the exception of one moderate adverse event. No clinically meaningful treatment-related changes were observed in clinical laboratory results, vital signs measurements, or ECG parameters.
Prior to the submission of the NDA, the company intends to complete some additional work to support a manufacturing site change. It is currently seeking a marketing partner for this product. Penwest is also developing a low-dose strength for this product, which will require an additional clinical trial that it anticipates will begin dosing in the second quarter of the year.