Corgentech Inc. pivotal phase 3 trial results from the second of two phase 3 trials demonstrating that children undergoing medical procedures requiring venipunctures and intravenous line placements treated with ALGRX 3268 experienced significantly superior pain relief in just one to three minutes versus those receiving placebo. Importantly, the study also showed ALGRX 3268 was well tolerated.
According to the company release, Corgentech plans to file a new drug application (NDA) with the US Food and Drug Administration (FDA) in mid-2006 for ALGRX 3268, the first of three product candidates the company is developing for pain management.
ALGRX 3268 utilises a needleless injection system to locally deliver lidocaine into the skin to anesthetise the skin and relieve pain very rapidly. Approximately 18 million venipunctures and intravenous line placements occur each year in the largest children's hospitals and academic institutions in the United States.
"With an onset of action of one to three minutes, ALGRX 3268 provides a unique fast-acting, local anaesthetic for reducing pain associated with peripheral venous access and intravenous insertion procedures in children," said Dr. Elliot J. Krane, principal investigator for the study and the director of pain management at the Lucile Packard Children's Hospital and professor of anaesthesia and paediatrics at Stanford University School of Medicine.
"Needlesticks are among the most distressing events for children undergoing medical treatments or procedures. In addition to being extremely fast-acting, ALGRX 3268 is well tolerated, which could make it an ideal new treatment to help physicians and nurses ease the pain and anxiety of their pediatric patients," added Dr. Krane.
This second of two pivotal phase 3 trials was conducted at nine centers in the United States and enrolled 535 patients, three to 18 years of age. Two hundred sixty-six patients received a placebo and 269 patients received ALGRX 3268 one to three minutes before undergoing medical procedures requiring venipuncture or intravenous line placement at the back of hand or antecubital fossa.
"We met the primary endpoints of two pivotal phase 3 trials involving more than 1,000 patients, which we expect will enable us to obtain FDA approval for ALGRX 3268 in 2007," said John P. McLaughlin, chief executive officer of Corgentech.
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialisation of novel therapeutic treatments for pain and inflammation.