A Randomized, Open Label, 2-Way Crossover Study to Assess the Pharmacokinetic Characteristics and Skin Irritation of Murupe(R) Patch Compared with Trast(R) Patch in Healthy Volunteers

BACKGROUND: A piroxicam patch has been widely used to treat musculoskeletal pain. The aim of this study was to assess the pharmacokinetic (PK) characteristics and skin irritation of Murupe(R) patch (piroxicam 96 mg) compared with Trast(R) patch (piroxicam 96 mg) in healthy volunteers. METHODS: A randomized, open-label, 2-way crossover study was conducted in 12 healthy Korean male subjects. They were allocated to one of the two treatment sequences of RT and TR (R, reference drug, Trast(R) patch; T, test drug, Murupe(R) patch). Each patch was applied to the subject once during 48 hours. Serial blood samples were collected up to 72 hours after removing the patch and plasma concentrations were determined by high performance liquid chromatography. Safety was monitored and the skin irritation potential was assessed. RESULTS: The plasma concentration-time profile during 48 hours showed an exponential increase in both of two patch products. Mean C(max) and AUC(last) values were not statistically different between two patch groups. Mean AUC[0-48h] was lower in Murupe(R) patch group than that in Trast(R) patch group; 806.4 and 1196.5 ng.h/mL. However, the mean AUC[48-120h] value tended to be higher in Murupe(R) patch group, implying more delayed excretion than in Trast(R) patch group; 2724.7 ng.h/mL and 1989.2 ng.h/mL. The overall results of skin irritation potential test showed no clinically significant differences between two patch groups. CONCLUSION: Mean Cmax and AUC(last) values in Murupe(R) patch group were comparable to those in Trast(R) patch group. Murupe(R) patch was safe and well tolerated in healthy male subjects.

Efficacy of Piroxicam Patch Compared to Lidocaine Patch for the Treatment of Postherpetic Neuralgia

BACKGROUND: The lidocaine patch has been effectively used as a first-line therapy to treat neuropathic pain such as postherpetic neuralgia (PHN). OBJECTIVE: To evaluate the safety and efficacy of the topical piroxicam patch as a treatment option for the treatment of PHN. METHODS: Eighteen patients completed a 3-session study, applying three different patches (lidocaine, piroxicam and control) in random order. A maximum of three patches were applied to the most painful area for three consecutive days (12 hours on followed by 12 hours off). Each session was conducted at least seven days apart. The changes in visual analog scale (VAS) scores based pain intensity, quality of sleep and adverse effects were recorded. RESULTS: When compared to the control, both the lidocaine and piroxicam patches significantly reduced the mean VAS scores of pain intensity of all different types. However, the lidocaine patch was better at reducing allodynia, whereas the piroxicam patch was more effective for dull pain. The lidocaine patch worked faster than the piroxicam patch for the response to overall pain relief. CONCLUSION: The results of this study suggest the use of the piroxicam patch for dull pain and in patients where the lidocaine patch is contraindicated.

Study on Clinical Efficacy of Pixoicam Pathch ( Trast(r) ) in Patients with Rheumatoid Arthritis / 대한류마티스학회지

OBJECTIVE: To evaluate the effects of piroxicam patch(Trast) in rheumatoid arthritis patients with knee joint pain and swelling and to determine the concentration of plasma and synovial fluid following patch application. METHODS: Twenty-two patients with rheumatoid arthritis participated in a double-blind, placebo-controlled study. The patients were instructed to apply piroxicam or placebo patch at one knee and re-apply it every other day for 2 weeks. They had washout period for 2 weeks and then applied the other patch for 2 weeks at the same joint. The patients recorded knee joint pain using visual analog scale. Knee joint swelling and tenderness were assessed before and after application of piroxicam and placebo patch. Complete blood count, AST, ALT, BUN, creatinine, joint fluid analysis were also done. Piroxicam concentration in plasma and synovial fluid were measured by high performance liquid chromatography(HPLC) after 2 weeks of piroxicam patch application. RESULTS: Knee joint pain improved significantly after the application of piroxicam patch for 2 weeks(visual analog scale, 56. 2+5. 9m vs 48. 2+5. 7mm, p=0. 03 by Wilcoxon signed rank test). There was no significant change in white cell count of synovial fluid, peripheral blood cell count, chemistry, C-reactive protein and erythrocyte sedimentation rate. In terms of adverse effects, mild gastrointesti nal disturbance(8/21 cases, 38%) and local side effects such as pruritus and ery thema(3/21 cases, 14%) were developed, which were insignificant compared with control groups(30%, 15% respectively). Piroxicam concentrations in plasma and synovial fluid after the application of piroxicam patch were 0. 129+0. 04ug/ ml (mean+SE) and 0. 644+0. 202ug/ml respectively. CONCLUSIONS: Piroxicam patch is a safe and effective therapeutic modality for knee joint pain in patients with rheumatoid arthritis. Mild adverse effects such as gastrointestinal disturbance and local side effects were noted. Piroxicam concentration was higher in synovial fluid than in plasma following the application of piroxicam patch.