Javelin Pharmaceuticals is reporting positive results from a Phase III trial of Dyloject, an analgesic for postoperative abdominal surgery. The drug met primary and secondary efficacy endpoints in the first of two planned trials. "Analysis of our previous trial results convinced us that Dyloject not only worked more rapidly than prior diclofenac formulations, but also was more potent," said Dr. Daniel Carr, Javelin's CEO/CMO.
The company also updated analysts on its PMI-150 (intranasal ketamine). At a pre-NDA meeting the FDA recommended that Javelin conduct another Phase III efficacy trial of PMI-150 for acute pain study in same-day orthopedic surgery.
- see Javelin's release