Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and
marketer of specialty pharmaceutical products for pain management, today
announced that its New Drug Application (NDA) submitted on December 2,
2009 to the US Food and Drug Administration (FDA) for its
investigational product candidate, Dyloject™ (diclofenac sodium)
Injection, has received an FDA PDUFA date of October 3, 2010. This NDA
review is in support of US marketing approval and registration of
Dyloject 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 United States as a single
agent for the management of acute moderate-to-severe pain in adults
since ketorolac in 1990.
Javelin’s NDA 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
previously reported, patient populations included the elderly (65 years
of age and older) and patients with mild-to-moderate renal or mild
hepatic insufficiency. In addition, over 400 Dyloject-treated patients
received blood thinning agents during routine postoperative care. The
two major efficacy trials for Dyloject achieved their primary endpoints
(summary of pain intensity differences over the duration of the trial).
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.