Javelin Pharmaceuticals has announced that 3 patients began treatment in the second of two planned phase III clinical studies for its injectable (nonsteroidal anti-inflammatory drug) NSAID, Dyloject (injectable diclofenac sodium). This US study will enrol patients with moderate-to-severe postoperative pain following elective orthopaedic surgery.
Patient enrolment was recently completed in the first pivotal phase III study, and an announcement of top-line results is expected by year end. This first study focused on postoperative pain after elective abdominal surgery.
"This second phase III study is the last clinical efficacy trial anticipated for Javelin prior to filing its New Drug Application (NDA) for Dyloject in the US," said CEO, CMO Dr Daniel Carr, "We are pleased to have met yet another important corporate milestone on time. This trial advances the US Dyloject programme towards commercialisation as we prepare for its anticipated launch in Europe."
A total of 240 postoperative elective orthopaedic surgical patients will be randomised in this multi centre, placebo- and comparator-controlled study. They will receive one of three dose levels of Dyloject, one of two dose levels of IV ketorolac, or IV placebo. Patients with moderate-to-severe pain following elective orthopaedic surgery will eligible for treatment for up to five days. The primary measure of efficacy will be the Sum of Pain Intensity Differences (SPID) as measured on the 0-100 mm Visual Analog Scale (VAS). In this double-blinded study, patients will receive treatments whose identity will not be known either to them or the investigators.
Dyloject, is an injectable formulation of diclofenac. Diclofenac is a prescription NSAID that is widely prescribed to treat post-operative pain due to its combination of effectiveness and tolerability. Dyloject has the potential to provide an attractive alternative to other NSAIDs for the treatment of post-operative pain, and to decrease the need for morphine or other opioids in this setting. There still exists an underserved medical need for a safe and effective injectable NSAID in the hospital setting. Dyloject is presently under review for marketing approval in the UK for the treatment of acute moderate-to-severe pain. Subsequent submissions and approvals in other European countries are anticipated through a regulatory strategy following the Mutual Recognition Process.