Javelin Pharmaceuticals’ Dyloject NDA receives FDA PDUFA date

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010. This NDA review 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.

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.

Source:

Javelin Pharmaceuticals, Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Efficacy of acupuncture in improving sleep quality for Parkinson's patients