Penwest Begins Dosing Phase IIa Clinical Study Of Nalbuphine ER

Armen Hareyan's picture

Penwest Pharmaceuticals has begun dosing patients in its Phase IIa study to evaluate the analgesic efficacy of nalbuphine hydrochloride extended release tablet formulation (nalbuphine ER), a product the Company is developing for the treatment of chronic pain.

Nalbuphine ER, designed to be taken as a twice-daily tablet, uses Penwest's TIMERx drug delivery technology. The Company previously conducted multiple Phase I studies on this formulation of nalbuphine ER to establish the pharmacokinetic profile and generate safety data. The Company has also conducted a Phase IIa study of this formulation in which a single dose of nalbuphine ER positively reduced mean pain intensity in a dose-dependent manner over a 12-hour study period when compared to placebo. Nalbuphine is currently available only as an injection medication.


The main objective of this Phase IIa study is to evaluate the analgesic efficacy of Nalbuphine ER in patients with chronic pain secondary to osteoarthritis of the knee or hip. The study will employ a randomized, double-blind, placebo controlled design, with a forced weekly dose escalation and a total dosing period of 21 days. The Company plans to conduct the study at 24 sites in the United States and has a planned enrollment of 216 patients.

The Company expects topline results from this Phase IIa clinical study to be available in the first quarter of 2008.

Jennifer L. Good, Penwest's President and CEO said, "We are very pleased to initiate this Phase IIa trial and are hopeful that this study will generate the information necessary for us to advance nalbuphine ER into the next study which we are targeting to begin in mid-2008. This is an important step in establishing the proof of concept in chronic pain for this product."

Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for diseases of the nervous system. At the core of this strategy, Penwest applies drug delivery technologies, including its own proprietary technologies, to new and existing compounds to enhance their therapeutic profiles. The launch by Endo Pharmaceuticals in mid-2006 of Opana ER (oxymorphone hydrochloride extended-release tablets) formulated with the Company's TIMERx extended release delivery technology demonstrates the execution of this strategy and the value of the Company's TIMERx technology. The Company is currently applying its expertise to a pipeline of potential products that are in various stages of development. The Company intends to commercialize these products independently or through third party alliances.