FDA Calendar Updates: ACUR, BSX, JAV, KG

Acura Pharma (NASDAQ:ACUR): On 6/23/09, ACUR announced the receipt from the FDA of a review letter related to its pending New Drug Application (NDA) for Acurox (oxycodone + niacin) tablets. On 2/22/09, Acurox was granted a priority review classification by the FDA with a PDUFA action date of 6/30/09. FDA stated in the review letter that their comments are preliminary, subject to change, and do not reflect a final decision on the information reviewed or a review of the entire NDA.  

Based on the review letter, ACUR does not believe Acurox will receive NDA approval on the PDUFA date. ACUR has an exclusive licensing agreement with King Pharma (NYSE:KG) for the development and commercialization of certain opioid analgesic products utilizing the Company's Aversion Technology, which includes an exclusive license for Acurox.

Javelin Pharma (AMEX:JAV): On 6/23/09, JAV reported that it has completed its open-label multi-dose, multi-day, observational safety study of Dyloject in the U.S. and that the study successfully met its objective. The objective of the study was to evaluate the safety of Dyloject following IV bolus administration of multiple doses over multiple days in patients aged 18 to 85 with acute post-operative pain. 856 patients successfully completed the study, receiving at least 8 doses of Dyloject over a 48 hour period.

The successful completion of this study satisfies the Company's goal of having well in excess of a 1000-patient safety data base for its Dyloject NDA filing with the FDA, which is planned for the fall of 2009 at the same 37.5 mg dose used in the study. Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the U.S. and already marketed in the U.K. In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints.

Boston Scientific (NYSE:BSX): On 6/23/09, BSX announced that the landmark MADIT-CRT trial has met its primary endpoint. Preliminary results show the Company's cardiac resynchronization therapy defibrillators (CRT-Ds) to be associated with a significant 29% reduction (p=0.003) in death or heart failure interventions when compared to traditional implantable cardioverter defibrillators (ICDs).

MADIT-CRT demonstrates that early intervention with cardiac resynchronization therapy can slow the progression of heart failure. It is the world's largest randomized NYHA Class I/II CRT-D trial, with more than 1,800 patients enrolled at 110 centers in 14 countries. The trial is being conducted under the leadership of Principal Investigator Arthur J. Moss, M.D., Professor of Medicine at the University of Rochester Medical Center.

Disclosure: No positions.