A randomized, multi-Center, double-blind, placebo-controlled phase II/III trial to evaluate the efficacy, tolerability and safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the treatment of pain

Abstract

MRX-7EAT Etodolac-Lidocaine Topical Patch (4.4% w/w) is a novel, selective COX-2 inhibitor, non-steroidal anti-inflammatory drug (NSAID) patch, developed by using a novel transdermal delivery system based on a proprietary ionic liquid technology, ion-pair formulation paired with appropriate counter ion presence which allows for efficient transdermal delivery to local tissues. Etodolac-lidocaine is a new salt of etodolac with equimolar amounts of lidocaine. Phase I study of MRX-7EAT showed that Etodolac-Lidocaine patch has higher skin permeability than Etodolac-alone patch for local transdermal administration. No serious adverse event or death occurred. We conducted a Phase II/III, randomized, multi-center, double-blind, placebo controlled study in the U.S. to evaluate the safety and the efficacy of MRX-7EAT Etodolac-Lidocaine Topical Patch once daily application for 14 days in relieving shoulder acute pain due to recent onset of supraspinatus, subacromial bursitis/tendonitis and/or subdeltoid bursitis as described for > 24 hours and < 7 days and a Current Pain Intensity (CPI) of > 6 but < 8 on an 11-point Numeric Pain Rating Scale (NPRS) at the time study entry. The efficacy primary endpoint is a Mean of all 16 CPI scores collected on Days 11 through 14 on a 0-10 NPRS at four time points. This study enrolled approximately 210 subjects aged in 14 years old or older at 30 sites to achieve 95 evaluable subjects per group for 11 months, from December 2011 to October 2012. Currently, this study has been completed the enrollments. However, any result is not obtained because the data has not been locked. At this moment when all patients were completed this study, no serious adverse event has been occurred. The final study result plans to be presented at 32nd Annual Scientific Meeting of American Pain Society, 2013. MRX-7EAT Etodolac-Lidocaine Topical Patch (4.4% w/w) is a novel, selective COX-2 inhibitor, non-steroidal anti-inflammatory drug (NSAID) patch, developed by using a novel transdermal delivery system based on a proprietary ionic liquid technology, ion-pair formulation paired with appropriate counter ion presence which allows for efficient transdermal delivery to local tissues. Etodolac-lidocaine is a new salt of etodolac with equimolar amounts of lidocaine. Phase I study of MRX-7EAT showed that Etodolac-Lidocaine patch has higher skin permeability than Etodolac-alone patch for local transdermal administration. No serious adverse event or death occurred. We conducted a Phase II/III, randomized, multi-center, double-blind, placebo controlled study in the U.S. to evaluate the safety and the efficacy of MRX-7EAT Etodolac-Lidocaine Topical Patch once daily application for 14 days in relieving shoulder acute pain due to recent onset of supraspinatus, subacromial bursitis/tendonitis and/or subdeltoid bursitis as described for > 24 hours and < 7 days and a Current Pain Intensity (CPI) of > 6 but < 8 on an 11-point Numeric Pain Rating Scale (NPRS) at the time study entry. The efficacy primary endpoint is a Mean of all 16 CPI scores collected on Days 11 through 14 on a 0-10 NPRS at four time points. This study enrolled approximately 210 subjects aged in 14 years old or older at 30 sites to achieve 95 evaluable subjects per group for 11 months, from December 2011 to October 2012. Currently, this study has been completed the enrollments. However, any result is not obtained because the data has not been locked. At this moment when all patients were completed this study, no serious adverse event has been occurred. The final study result plans to be presented at 32nd Annual Scientific Meeting of American Pain Society, 2013.