Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (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 United States as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990.
“Our NDA submission for Dyloject is a significant milestone for Javelin. It reflects our 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,” stated Martin J. Driscoll, CEO of Javelin Pharmaceuticals, Inc. “I am proud of my fellow colleagues who worked diligently to complete today’s NDA submission and the many investigators who participated in our Dyloject clinical development program.”