Monday June 24, 7:38 am Eastern Time
Press Release
SOURCE: Endo Pharmaceuticals Holdings Inc.
Endo Pharmaceuticals Announces Results from MorphiDex(R) Phase III Clinical Trial
CHADDS FORD, Pa., June 24 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP; ENDPW), today announced results from the first of its three Phase III clinical trials for its development product, MorphiDex®.
The primary endpoint of the study was to demonstrate that the average daily dose of morphine given in combination with the N-methyl-D-aspartate (NMDA)-receptor antagonist, dextromethorphan is less than the average daily dose of morphine when given as morphine alone in order to maintain the same degree of pain control over a three-month period. No statistically significant difference in average daily morphine dose was observed in the morphine sulfate:dextromethorphan (MS:DM) group compared to the morphine sulfate group.
A secondary endpoint of the study was to determine if the combination of morphine and dextromethorphan minimizes the rate of escalation of daily morphine dose compared with morphine alone over the study period in order to maintain satisfactory pain control. No statistically significant difference in the percentage change from baseline in daily morphine dose averaged by week from the commencement of the double-blind study period to the completion of the double-blind study period was observed.
Carol A. Ammon, Chairman and Chief Executive Officer of Endo Pharmaceuticals, said, "Although we are disappointed by these study results, we will continue to analyze the data from this study and await the results of our other two ongoing Phase III clinical studies. As you may be aware, this study is the first of Endo's three Phase III clinical trials that we undertook for MorphiDex®. Enrollment for the second of these trials has recently been completed, and we expect enrollment for the third of these trials to be completed in the next couple of weeks. We expect to be able to announce the results of the second and third of these clinical trials in the fourth quarter of this year. Until we are able to analyze the data from these studies, we will not be in a position to resubmit an amendment to the existing MorphiDex® new drug application with the FDA."
This clinical trial compared MorphiDex® (morphine and the N-methyl-D- aspartate (NMDA)-receptor antagonist, dextromethorphan) to immediate-release morphine sulfate among chronic pain patients. This pivotal, randomized, double-blind trial enrolled 193 chronic pain patients from 20 centers in the United States of America. The protocol called for patients enrolled in the study to be dosed for a three-month period in a double-blind fashion. Prior to this three-month double-blind period, patients were stabilized at a predefined level of pain control with their current opioid medication during a seven to 21-day run-in period in order to establish the morphine-equivalent daily dose needed to maintain satisfactory pain control. Following this open- label run-in period, patients were randomized to one of two double-blind treatment groups - receiving either MS:DM 15:15mg or immediate-release morphine sulfate 15 mg capsules, both of which are identical in appearance. These patients started this three-month double-blind period with 50% of their morphine-equivalent daily dose that had been established during the run-in period. During the three-month double-blind period, patients were permitted to self-titrate their dose of medication in order to achieve the predefined level of pain control. The study population consisted of 193 patients (101 men and 92 women). The mean age of the patients was 49 years, ranging between 22 and 75 years. |
