NEW YORK, Aug. 18 /PRNewswire/ -- An established and safe pain reliever for moderate-to-severe post-surgical pain may soon be commercially available as an easily administered simple injection. This new injectable bolus formulation of diclofenac is intended for patients who are unable to swallow tablets or pills.
New York-based Innovative Drug Delivery Systems (IDDS) is currently in the final stages of testing diclofenac sodium injection called Dyloject(TM). According to Dr. Daniel Carr, chief executive officer and chief medical officer for IDDS, until now there has been no way to give it as a convenient, single injectable bolus dose to patients unable to swallow tablets after operations or trauma.
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 United States.
"When taken orally as a tablet, diclofenac has a proven safety and efficacy record. IDDS' new, injectable form, Dyloject(TM) -- like our other product candidates -- offers a simple, safe, cost-effective answer to complex analgesic problems," Dr. Carr says.
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 4 hours after dosing. Patients with moderate-to-severe post-surgical pain given a single injection of Dyloject experienced no treatment-related serious or significant adverse events. The most common side effects reported, regardless whether patients received placebo, Dyloject or Voltarol, were phlebitis (6.5%), headache (4.5%), fatigue (2.6%) and haematuria (2.6%).
The incidence of phlebitis in patients receiving Dyloject was half the rate that occurred with the slowly infused medication, Voltarol(R). 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. "This study is a vital first step in changing the face of pain therapy," says Dr. Carr.
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Innovative Drug Delivery Systems