Penwest says enrollment complete in phase 2a trial of PW4142 for pain

By E. Janene Geiss

Philadelphia, Dec. 15 - Penwest Pharmaceuticals Co. announced Thursday that it has completed patient enrollment for its phase 2a 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, company officials said in a news release.

The phase 2a trial is a pharmacokinetic-pharmacodynamic 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, officials said.

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 prespecified intervals over the 12- hour period following dosing.

Blood samples for determination of plasma concentrations of PW4142 also will be collected for 24 hours post-dose.

The company said it expects to release data from the trial in the first quarter of 2006.

Penwest said it formulated PW4142 using its proprietary Geminex 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, officials said.

Penwest completed a phase 1 study earlier this year that administered PW4142 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, officials said.

Penwest, based in Danbury, Conn., makes pharmaceutical products based on oral drug delivery technologies with a focus on products that address diseases of the central nervous system.

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