Pain Management
We have two products in human trials for the acute treatment of Moderate-To-Severe pain; DPI-3290 i.v. and DPI-125 i.v.
Our licensing partner for DPI-3290 i.v., Organon, has completed a large Phase 2 clinical trial of DPI-3290 i.v. for acute post-operative pain. Organon is now conducting additional phase 2 trials to complete dose selection prior to initiating Phase 3 trials.
Prior to the Organon license, we completed a Phase 1 clinical trial of DPI-3290 i.v. at Duke University using a normal human volunteer pain model. DPI-3290 i.v. was dose-ranged to replicate the clinical analgesic range of the potent mu-agonist fentanyl, from the small doses used in short-stay procedures to the large doses used for deep analgesia required for bone and joint or thoracic surgery. At all equianalgesic doses, DPI-3290 i.v. demonstrated substantially less respiratory depression and vomiting than historical fentanyl controls.
We are also developing additional intravenous mixed delta/mu analgesics. DPI-125 i.v. is our follow-on to DPI-3290 i.v. and may possess a better safety/efficacy profile than DPI-3290 i.v. We have completed a successful Phase 1 trial for DPI-125 i.v. and plan to move rapidly to a Phase 2 efficacy study in early 2003.
We are exploring multiple routes of administration and delivery mechanisms for the use of DPI-125 for the treatment of chronic pain.