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.An ongoing phase III trial of AlgoRx Pharmaceuticals' and Corgentech's pain drug ALGRX 3268 has produced positive data. The companies now plan to file a new drug application for the product in the first half of 2006.
Subscribe to our email newsletter
ALGRX 3268 is a fast-acting local anesthetic administered into the skin by powder injection and aimed at reducing pain associated with venipuncture procedures such as blood draws and intravenous line placements.
In a 574-pediatric patient trial, ALGRX 3268 has demonstrated statistically significantly less pain compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues. This study was conducted at six centers in the US in patients 3 to 18 years of age.
A second phase III trial of ALGRX 3268 with an identical clinical trial protocol is being conducted in approximately 500 patients, and data from this second pivotal trial are expected to be reported within two months.
“We are very pleased with the outcome of this study which shows that ALGRX 3268 is significantly more beneficial than any of the topical local anesthetics currently being offered on the market,” stated Dr Ronald Burch, CEO of AlgoRx. “Subjects who received ALGRX 3268 experienced less pain and onset was rapid, within one to three minutes compared to up to 60 minutes it takes for the most commonly used topical local anesthetics to offer analgesia.”