Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Penwest Pharmaceuticals has begun dosing patients in its phase IIa study to evaluate the analgesic efficacy of nalbuphine hydrochloride extended release tablet for the treatment of chronic pain.
Subscribe to our email newsletter
Nalbuphine ER, designed to be taken as a twice-daily tablet, uses Penwest’s drug delivery technology. 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. Penwest plans to conduct the study at 24 sites in the US 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 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.”