By Emma Hitt, PhD
HONOLULU -- January 30, 2009 -- Diclofenac potassium liquid-filled soft gelatine capsules (DPSGC) appear to provide pain relief with good tolerability in patients undergoing third-molar extraction, according to the findings of 2 randomised trials presented here at the American Academy of Pain Medicine (AAPM) 25th Annual Meeting.
Diclofenac potassium is a nonsteroidal anti-inflammatory drug that is prescribed for treatment of mild to moderate pain, such as that observed in the postsurgical setting. The liquid-filled soft gelatine capsule formulation contains 25 mg of diclofenac potassium for immediate-release oral administration.
"The data from these well-designed phase 3 trials clearly illustrate that this product was well tolerated and safe in patients undergoing dental surgery," said lead researcher Robert J. Noveck, MD, PhD, MDS Pharma Services, Inc., Neptune, New Jersey, in a presentation on January 29.
Dr. Noveck and colleagues assessed the safety and efficacy of DPSGC in 2 randomised trials of adult patients who underwent third-molar extraction and were experiencing a level of pain of at least 50 out of 100 mm on a visual analogue scale within 4 hours after surgery.
Patients received single doses of DPSGC 25, 50, or 100 mg or placebo and were assessed for 6 hours after treatment. In the 2 trials, one with 265 patients and the other with 249 patients, pain scores were significantly improved in all DPSGC groups compared with placebo (P < .0001). The outcomes followed a trend for a dose response.
Relief from pain was achieved at the lowest dose of 25 mg within 22 to 25 minutes, with meaningful relief achieved at 45 to 52 minutes (P < .0001 compared with placebo). In addition, significantly fewer patients used rescue medication in the treatment arms compared with placebo (P <= .0017).
Adverse events occurred at a rate comparable to that of placebo, and were reported in 8% to 13% of patients.
Pharmacokinetic studies have shown that DPSGC gets into the circulation quicker and achieves higher plasma levels at a lower dosage compared with certain other analgesics, Dr. Noveck noted, and may have a more rapid onset of analgesia with a long duration of action.
Xanodyne Pharmaceuticals, Inc., received an approvable letter from the US Food and Drug Administration for DPSGC in July 2008 and is currently awaiting approval for marketing in the United States.
Funding for the study was provided by Xanodyne.
[Presentation title: The Safety and Efficacy of Oral Diclofenac Liquid Filled Soft Gelatin Capsule in Patients With Postsurgical Dental Pain. Abstract 230]
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