FDA Receives New Drug Application Of Javelin Pharmaceuticals For Dyloject

Javelin Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its investigational product candidate, Dyloject (diclofenac sodium) injection, for the management of acute moderate-to-severe pain in adults.

If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the US as a single agent for the management of acute moderate-to-severe pain in adults.

Javelin’s submission includes 16 clinical studies evaluating over 2000 subjects dosed with Dyloject. It includes over 1300 US patients in two multi-dose, multiple-day placebo-controlled Phase 3 pivotal efficacy studies and one multi-dose, multiple-day open label safety study.

As reported earlier, patient populations included the elderly (65 years of age and older) patients with mild-to-moderate renal or mild hepatic insufficiency. In addition, over 400 Dyloject-treated patients received blood thinning agents during routine post-operative care.

The two efficacy trials for Dyloject achieved their primary endpoints (summary of pain intensity differences over the duration of the trial) and also showed reductions in postoperative opioid consumption of 43.5% and 61.5% compared to placebo. Moreover, the NDA submission includes pharmacovigilance data on Dyloject from the UK, where it has been marketed following its approval in the fourth quarter of 2007.

Dyloject has the potential to provide an alternative for the management of acute moderate-to-severe pain as a single agent. In clinical studies it reduced the need for morphine or other opioids.

Martin Driscoll, CEO of Javelin, said: “The NDA submission for Dyloject is a milestone for Javelin. It reflects commitment to patients suffering from acute moderate-to-severe pain, whose need for effective and safe analgesia in both the inpatient and day surgery settings is currently underserved.”