DANBURY, Conn., Oct. 26, 2007 (PRIME NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO) announced today that it has completed patient enrollment in its Phase IIa clinical trial of nalbuphine hydrochloride extended release tablet formulation (nalbuphine ER), a product the Company is developing for the treatment of chronic pain.
This Phase IIa trial is a randomized, double-blind, placebo controlled design, with a forced weekly dose escalation. The main objective of this trial is to evaluate the analgesic efficacy of nalbuphine 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(r) drug delivery technology. Penwest previously conducted multiple Phase I studies on this formulation to establish the pharmacokinetic profile and generate safety data. The Company has also conducted a Phase IIa study of this formulation for an acute pain model in which a single dose of nalbuphine ER 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 Company expects preliminary 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 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."
Penwest Pharmaceuticals
Penwest is a drug development 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. Penwest is currently applying its drug delivery and drug development expertise to a pipeline of potential products that are in various stages of development and that it intends to commercialize independently or through third party alliances.
Penwest Forward-Looking Statement
The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "potential" and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of Opana ER and our reliance on Endo for the commercial success of Opana ER, regulatory risks relating to drugs in development, including the timing and outcome of regulatory submissions and regulatory actions; uncertainty of success of collaborations; the timing of clinical trials, including the impact of enrollment rates; whether the results of clinical trials will warrant further clinical trials, warrant submission of an application for regulatory approval of, or warrant the regulatory approval of, the product that is the subject of the trial; whether the patents and patent applications owned by Penwest will protect the Company's products and technology; whether we can successfully prevent others from infringing our patents and other intellectual property; actual and potential competition; the need for capital; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2007, which risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release speak only as of the date of the statement made. Penwest disclaims any intention or obligation to update any forward-looking statements.
TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.