Wednesday, Javelin Pharmaceuticals Inc. (JAV) submitted a New Drug Application or NDA to the US Food and Drug Administration or FDA for its investigational product candidate, Dyloject or 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 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 comprehensive 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.
Javelin Pharmaceuticals, Inc., a specialty pharmaceutical company, engages in the research, development, and commercialization of products for the pain management market primarily in the United States and Europe.
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