The main objective of this trial is to evaluate the analgesic efficacy of nalbuphine extended release (ER). There are approximately 135 patients with chronic pain secondary to osteoarthritis of the knee or hip in the intent-to-treat population of this trial.
Nalbuphine ER, designed to be taken as a twice-daily tablet, is formulated using Penwest’s TIMERx drug delivery technology. Penwest previously conducted multiple Phase I studies on this formulation to establish the pharmacokinetic profile and generate safety data. The Company expects preliminary results from this phase IIa clinical study to be available in the first quarter of 2008.
Jennifer Good, Penwest’s president and CEO, said: “We are very pleased to have completed enrollment for this Phase IIa trial on schedule. This is an important step in establishing the proof of concept for treatment of chronic pain for this product. If this study generates positive results, we plan to advance nalbuphine ER into a Phase IIb trial in mid-2008.”