Pain Therapeutics on-track with Oxytrex PIII programme
Pain Therapeutics, of South San Francisco, CA, has enrolled over 350 patients in its first Phase III study with Oxytrex, a unique oral painkiller being developed by the company to treat patients who suffer from severe chronic pain.
Pain Therapeutics, of South San Francisco, CA, has enrolled over 350 patients in its first Phase III study with Oxytrex, a unique oral painkiller being developed by the company to treat patients who suffer from severe chronic pain.
'This Phase III clinical program remains right on-track with all of our expectations,' said Remi Barbier, Pain Therapeutics' president and chief executive officer. 'We have now enrolled over half of about 700 patients needed for our first Phase III study. The next critical milestone with Oxytrex will be to announce the initiation of a second Phase III study later this month.'
The company is conducting a comprehensive clinical program with Oxytrex to address the multiple needs of patients who suffer from severe chronic pain. The Company plans to conduct two large Phase III studies with Oxytrex. The first study was initiated in June 2003 and is designed to assess the efficacy and safety of Oxytrex in over 700 patients with severe low-back pain. The Company's second Phase III study with Oxytrex is scheduled to begin in March and will enroll 700 patients with severe osteoarthritic pain. The Company aims to complete patient enrollment for both of these studies later this year or in the first quarter of 2005, depending on the speed of patient enrollment and other factors.
About Oxytrex
Oxytrex is a unique oral painkiller that preferentially inhibits an excitatory effect of opioid receptors. This excitatory effect is believed to counteract analgesia (pain relief) and cause tolerance. Its inhibition enhances pain relief and minimises opioid tolerance. We believe Oxytrex represents the first new mechanism of action by an opiate drug since morphine was discovered over 100 years ago. Pain Therapeutics are developing Oxytrex to treat severe chronic pain, such as low-back pain or osteoarthritic pain, in the believe Oxytrex could be an effective substitute for oxycodone, a narcotic painkiller used to treat severe chronic pain. Sales of oxycodone exceed $1.5bn a year. Previous clinical results have shown that Oxytrex provides better enhanced pain relief and prolonged pain relief when compared with oxycodone. Published pre-clinical results also demonstrate that the technology used in Oxytrex results in a lack of opioid addiction, tolerance, physical dependence or withdrawal symptoms in animals.