DANBURY, Conn., Dec. 15 /PRNewswire-FirstCall/ -- Penwest Pharmaceuticals Co. today announced that it has completed patient enrollment for its Phase IIa trial of PW4142, an extended release tablet that the Company is developing for the treatment of pain. PW4142 is an oral formulation of a compound that is currently available only as an injection.
The Phase IIa trial is a pharmacokinetic-pharmacodynamic (PK-PD) investigation designed to correlate the level of analgesia in patients with the plasma level of drug. This trial is being conducted to determine if there is a dose-response relationship, as well as the duration of analgesia.
This trial includes 165 patients undergoing third molar extractions, a commonly used clinical pain model for evaluating the acute effectiveness of analgesics. Under the protocol, patients who experienced at least a score of four on the 0-to-10 NPRS pain scale following completion of their dental procedures receive blinded study medication (PW4142 or placebo) as a single dose. Pain relief is then evaluated at pre-specified intervals over the 12- hour period following dosing. Blood samples for determination of plasma concentrations of PW4142 will also be collected for 24 hours post-dose.
The Company expects to release data from the Phase IIa trial in the first quarter of 2006.
Penwest formulated PW4142 using its proprietary Geminex(R) technology, which is a dual release rate drug delivery system. The formulation of PW4142 will have plasma kinetics derived from both immediate release and controlled release components.
Penwest completed a Phase I study of PW4142 earlier this year. In this study, PW4142 was administered at multiple dose levels in healthy volunteers and showed relative oral bioavailability of approximately 123% when compared to the marketed injection formulation given by mouth, and the plasma levels of PW4142 were sustained over 12 hours.
Penwest Pharmaceuticals
Penwest develops pharmaceutical products based on innovative oral drug delivery technologies. We are focusing our development efforts principally on products that address diseases of the central nervous system. The foundation of our technology platform is TIMERx(R), an extended release delivery system that is adaptable to soluble and insoluble drugs and that is flexible for a variety of controlled release profiles. We have also developed two additional oral drug delivery systems, Geminex(R) and SyncroDose(TM). Geminex is a dual release rate drug delivery system that is designed to provide independent release of different active ingredients contained in a drug, and SyncroDose is a drug delivery system that is designed to release the active ingredient of a drug at the desired site and time in the digestive tract.
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; dependence on collaborators such as Endo Pharmaceuticals to, among other things, sell products for which the Company receives royalties, file for regulatory approvals, and/or to advance clinical development and commercialization of products; regulatory risks relating to drugs in development such as oxymorphone ER, 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, 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 Certain Factors That May Affect Future Results in Penwest’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2005, which risk factors are incorporated herein by reference. Penwest disclaims any intention or obligation to update any forward-looking statements.
Contacts: Investors: Media: Diane D’Alessandro Caroline Gentile/Jim Fingeroth (203) 796-3706 Kekst and Company (877) 736-9378 (212) 521-4800
Penwest Pharmaceuticals Co.
CONTACT: Investors - Diane D’Alessandro, +1-203-796-3706, or +1-877-736-9378, or Media - Caroline Gentile, of Kekst and Company, +1-212-521-4800,or Jim Fingeroth of Kekst and Company, +1-212-521-4800 all for PenwestPharmaceuticals Co.
