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news.Innovative Drug Delivery Systems is in the final stages of testing Dyloject, an injectable post operative painkiller using the active ingredient diclofenac sodium. Until now diclofenac has only been available in tablet form that cannot always be swallowed by patients following surgery.
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Currently, the only injectable form of diclofenac in Europe and other parts of the world is Voltarol. However, one limitation of the current European marketed form of the drug is the inability to deliver it immediately. Due to Voltarol’s insolubility, it must be delivered as a slow (30 minutes or longer) infusion of a solution that is freshly prepared for each patient. There is no injectable form of this product available in the US.
“When taken orally as a tablet, diclofenac has a proven safety and efficacy record. IDDS’ new, injectable form, Dyloject – like our other product candidates – offers a simple, safe, cost-effective answer to complex analgesic problems,” said Dr Daniel Carr, CEO and chief medical officer for IDDS.
The results of IDDS’ recent pivotal European phase II/III study of Dyloject demonstrated effective, sustained, and statistically significantly greater pain relief compared to placebo. Pain relief with Dyloject and Voltarol was comparable over the first four hours after dosing.
The incidence of phlebitis in patients receiving Dyloject was half the rate that occurred with the slowly infused medication, Voltarol. The rate of other side effects was comparable across treatment arms and consistent with established safety data worldwide for diclofenac.
Historically, diclofenac has been used to treat pain from inflammatory and degenerative forms of osteoarthritis, musculoskeletal conditions, acute attacks of gout, kidney stones, and after operations or trauma.