DANBURY, Conn., Jan. 19 /PRNewswire-FirstCall/ -- Penwest Pharmaceuticals Co. today announced that it has begun a Phase I safety study on a nalbuphine hydrochloride extended release tablet formulation (Nalbuphine ER) that the Company is developing for the treatment of pain.
Nalbuphine ER is a controlled release formulation of nalbuphine hydrochloride that Penwest is developing using its TIMERx(R) drug delivery technology. It is designed to be taken as a twice-daily tablet.
The primary objective of the Phase I safety study is to evaluate the safety and tolerability of the drug in healthy subjects of escalating dosage levels during multiple-dose steady-state administration. The secondary objective is to evaluate the pharmacokinetics of nalbuphine during steady-state administration and the effect of different nalbuphine ER dosage levels on typical opioid-related side effects.
Alan F. Joslyn, Ph.D., Penwest’s Senior Vice President of Research and Development, said, “This next step in the clinical development of nalbuphine ER demonstrates our progress in building our own product portfolio. We are conducting the Phase I safety study to enhance our understanding of the safety and pharmacokinetics of multiple doses of nalbuphine ER over the projected clinical dose range. We believe that, combined with the single dose safety and efficacy data we already have, this study will give us the information necessary to advance to the Phase II program we intend to begin in the first half of this year.”
The study will employ a randomized sequential dose-escalation design, with a planned total enrollment of 32 healthy adult subjects in two separate alternating cohorts. The study will examine a total of four dosage levels. Each subject will receive treatment at two different dose levels sequentially, with a number of days at each dosage level until steady state plasma concentrations are achieved.
The Company expects subject participation to be complete by the end of February, with data available in the second quarter.
About Penwest
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 of Opana(R) ER (oxymorphone hydrochloride extended-release tablets) in mid-2006 demonstrates the execution of this strategy and the value of Penwest’s TIMERx(R) extended release delivery technology. Penwest 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 and through third party alliances.
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 our products; regulatory risks relating to drugs in development, including the timing and outcome of regulatory action; uncertainty of success of collaborations; the timing of clinical trials and whether the results of clinical trials will warrant further clinical trials or warrant submission of an application for regulatory approval of, or the regulatory approval of, the product that is the subject of the trial; 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 November 9, 2006, 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.
Contacts: Investors: Media: Diane D’Alessandro Caroline Gentile/Jim Fingeroth Penwest Kekst and Company (203) 796-3706 (212) 521-4800 (877) 736-9378
Penwest Pharmaceuticals Co.
CONTACT: Investors: Diane D’Alessandro of Penwest, +1-203-796-3706,+1-877-736-9378; or Media: Caroline Gentile, or Jim Fingeroth, both ofKekst and Company, +1-212- 521-4800
