Javelin Pharmaceuticals, Inc, a leading developer of novel products for pain management, has enrolled the first patient in a planned phase-3, single-arm, open label observational safety study for its injectable NSAID, Dyloject (diclofenac sodium). The study is intended to supplement the company's summary of integrated patient safety data base, a part of its New Drug Application (NDA) for Dyloject in the United States, planned for submission to the FDA in 2009.
"We anticipate utilizing 80 clinical sites to expedite completion of this study and look forward to submitting an NDA for acute postoperative pain in the United States in 2009.The single-arm, open-label design of this safety study allows more rapid enrolment and data monitoring than our two double-blinded, pivotal phase-3 efficacy studies. In addition to our US clinical results for Dyloject to date, we are pleased by our post-marketing experience with Dyloject, since its UK launch in December 2007," said Daniel Carr, Javelin's chief medical officer & president.
The initiation of this single-arm open label observational safety study follows a successful pivotal phase-3 study of Dyloject in patients with postoperative abdominal pain. Additionally, the company plans to report top-line data later this year from a second pivotal phase-3 study, evaluating Dyloject in patients with postoperative orthopedic pain.
Dyloject is an injectable formulation of diclofenac in phase-3 clinical development in the United States and Marketed in the United Kingdom.
With corporate headquarters in Cambridge, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market.