AlgoRx Pharmaceuticals Inc. and Corgentech Inc. achieved positive data from the second of two Phase 3 trials of ALGRX 3268, a fast-acting local anaesthetic administered into the skin by powder injection and aimed at reducing pain associated with venipunctures and intravenous line placements.

The primary endpoint of the 535-peadiatric patient trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues.

This Phase 3 trial (004) was conducted at nine centres in the United States in patients 3 to 18 years of age. A total of 535 patients were administered a placebo (266 patients) or the local anaesthetic, ALGRX 3268 (269 patients) one to three minutes before having their procedures which required either venipuncture or intravenous line placement. The primary endpoint was pain upon needle insertion utilising the FACES pain scale, states a company release.

The first Phase 3 trial (003) of ALGRX 3268 with an identical clinical trial protocol was conducted in 574 patients, and data from this pivotal trial were reported in October 2005. The primary endpoint of the paediatric trial was achieved showing that treatment with ALGRX 3268 demonstrated statistically significantly less pain (p=0.007) compared with the placebo group. ALGRX 3268 was well tolerated and demonstrated no significant safety issues.

"We are very pleased with the data announced today and believe that the results from these two Phase 3 clinical trials demonstrate that ALGRX 3268 could be beneficial to patients by reducing local pain with a much faster onset of action than the drugs that are currently on the market. The data from these two trials will be included in a new drug application (NDA) for ALGRX 3268, which we expect to file with the FDA during 2006," stated Ronald M. Burch, chief executive officer of AlgoRx.

ALGRX 3268 represents a near-term product opportunity for which an NDA is expected to be filed in 2006. The product is aimed at reducing the pain associated with venipunctures and intravenous line placements. ALGRX 3268 is based on a needleless injection system called Powderject, which accelerates lidocaine particles, in powder form, into the epidermis in order to anesthetise nerves

Local anaesthetics for venipunctures and intravenous line placements is an underserved market. Currently, in the largest children's hospitals and academic institutions in the United States, approximately 18 million venipunctures and intravenous line placements occur each year. Of these, topical local anaesthetics are used in only approximately 2.1 million of these procedures given that the currently marketed products require from 10 to 60 minutes to offer benefit, compared with ALGRX 3268 which anaesthetises nerves within approximately one minute. With its fast onset-of-action, additional opportunities exist for ALGRX 3268 in the adult emergency room setting, haemodialysis and blood donation centres as well as physicians' offices and clinical laboratories.