Javelin Pharmaceuticals submits an NDA for Dyloject Injection

Dec 2 2009

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.”

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. 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 post-operative care. The two major efficacy trials for Dyloject achieved their primary endpoints (summary of pain intensity differences over the duration of the trial) and also showed reductions in postoperative opioid consumption of 43.5% and 61.5% compared to placebo. 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.

Diclofenac sodium, the active pharmaceutical ingredient in Dyloject is one of the most widely prescribed NSAIDs. Since its initial approval in the 1980s approximately 1 billion patient days of treatment with diclofenac are estimated worldwide. It is approved and marketed in a variety of forms in the US including several oral formulations, a topical gel, patch and ophthalmic drops. However, an injectable formulation is not yet available in the United States.

The Company believes there is a significant unmet medical need for non-opioid agents for the management of pain in patients with acute moderate-to-severe pain. Opioids such as morphine may cause undesirable side effects including nausea, vomiting, constipation, sedation, cognitive impairment and respiratory depression. Decreasing or eliminating the need for opioid medication can reduce many of these side effects.