Pharmaceutical Business review

Javelin’s Dyloject meets Phase III endpoints

Efficacy endpoints in this post-operative abdominal surgery trial were the sum of the pain intensity differences (SPID), versus pre-treatment pain scores, over 0-48 hours and 0-24 hours. Patients in this four-arm study receiving higher or lower Dyloject doses or ketorolac had markedly better (p<0.002 for all groups) SPID scores than the placebo group, with p<0.0001 for the higher dose Dyloject and ketorolac groups. This latest Dyloject trial, as earlier trials, did not reveal any unexpected safety signals. Adverse events were similar across all treatment groups. Thrombophlebitis (vein irritation) was significantly less with Dyloject than with ketorolac or placebo. Daniel Carr, CEO and chief medical officer of Javelin, said: "Analysis of our previous trial results convinced us that Dyloject not only worked more rapidly than prior diclofenac formulations, but also was more potent. Last year we filed patent applications to protect our insights into enhancing NSAID analgesic potency. The ability to use lower doses of an NSAID while achieving equal pain relief has important safety implications. Our new pivotal trial confirms that doses of Dyloject 50% and 75% lower than the standard dose of the prior diclofenac formulation achieved clinically meaningful analgesia. Our second pivotal Phase III trial, already well underway, is intended to extend the present abdominal surgery results to orthopedic surgery."