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news.Intrac and its subsidiary Innovative Drug Delivery Systems have said that a pivotal European phase II/III study of Dyloject met its primary endpoint of superior pain relief over four hours compared to placebo and therapeutic non-inferiority to Voltarol.
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Dyloject utilizes the same active ingredient as Voltarol, but is given as a single, brief injection, whereas Voltarol requires a slow (30 minutes or longer) infusion of a solution that is freshly prepared for each patient, and is not available in the US.
According to Dr Daniel Carr, CEO and chief medical officer of IDDS: “For years clinicians have pursued ways to boost pain relief and reduce the dose of morphine needed to control acute, moderate-to-severe pain. Diclofenac has proven safety and efficacy, but until now there has been no way to give it as a single intravenous dose to patients unable to swallow tablets after operations or trauma.”
In this blinded study, a total of 155 post-surgical patients were randomized to receive either a single bolus intravenous injection of Dyloject, a 30 minute intravenous infusion of Voltarol, or placebo.