Javelin Pharmaceuticals, Inc, a leading developer and marketer of specialty pharmaceutical products for pain management, announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (US FDA) for its investigational product candidate, Dyloject (diclofenac sodium) Injection, has been accepted for formal review. The company expects to learn the Dyloject NDA's PDUFA date from the US FDA in the next few weeks. The NDA is in support of US marketing approval and registration of Dyloject 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.
"Acceptance by the US FDA of Javelin's comprehensive NDA submission for Dyloject marks a significant regulatory milestone towards our goal of commercialization of Dyloject in the US. My colleagues and I are proud of this major achievement and are committed with Javelin's merger partner, Myriad Pharmaceuticals, Inc. to developing and commercializing new alternatives for patients suffering from acute moderate-to-severe pain. We look forward to working with the US FDA to facilitate the review of the Dyloject NDA," stated Eric Lang, VP Clinical Research of Javelin Pharmaceuticals, Inc.
Javelin's NDA 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 postoperative care. The two major efficacy trials for Dyloject achieved their primary endpoints (summary of pain intensity differences over the duration of the trial). 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 nonopioid agents for the management of pain in patients with acute moderate-to-severe pain. Opioids such as morphine can cause undesirable side effects including nausea, vomiting, constipation, sedation, cognitive impairment and respiratory depression. Decreasing or eliminating the need for opioid medication may reduce many of these side effects.
Dyloject has the potential to provide a novel alternative for the management of acute moderate-to-severe pain as a single agent.
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 acute pain management market.