MorphiDex® (morphine sulfate/dextromethorphan hydrobromide combination) in the treatment of chronic pain: Three multicenter, randomized, double-blind, controlled clinical trials fail to demonstrate enhanced opioid analgesia or reduction in tolerance

1区 · 医学

Article

作者: Tina Ma ; David Lee ; Thomas G. Schlagheck ; Barbara Nagle ; Bradley S. Galer

While many pre-clinical and clinical studies have suggested that the addition of N-methyl-D-aspartate (NMDA) receptor antagonists, such as dextromethorphan (DM), to opioid analgesics, such as morphine (MS), may enhance the analgesic effects and prevent the tolerance that may result from chronic opioid administration, others have not. The potential for reduced doses, enhanced opioid analgesia, and decreased analgesic tolerance associated with the MS/DM combination were evaluated in a series of three large, randomized, double-blind, parallel group, phase 3, multicenter trials each of 3 months duration in patients with chronic, non-malignant, non-neuropathic pain. To evaluate these unique endpoints, novel study designs were employed. In Study A, patients received fixed doses of MS or MS/DM, based on the stable dose of MS/DM attained during a Run-in period; changes from baseline in average daily pain intensity were compared. In Studies B and C, patients self-titrated doses of MS or MS/DM, based on stable doses of MS or other opioids attained during Run-in periods, to maintain pain relief; percentage changes from baseline in MS (or MS-equivalent) doses were compared. No statistically significant differences between treatment groups in any primary or secondary efficacy variables were demonstrated in any trial. These results suggest that adding the NMDA antagonist, dextromethorphan, to opioids does not add any clinical benefit.

2002-03-01·Current opinion in investigational drugs (London, England : 2000)

EN-3231. Endo Pharmaceuticals.

Article

作者: Monck, Nat

Endo (which acquired Algos in July 2000) has developed EN-3231, a combination of morphine and dextromethorphan, for the treatment of moderate-to-severe chronic pain. In October 1998, the FDA accepted for filing the company's NDA submission on EN-3231, which was submitted in August 1998. However, in August 1999, Algos received a 'non-approvable' letter from the FDA for EN-3231. In September 2000, the company met with the FDA to discuss what information the FDA required in order to approve EN-3231. The FDA requested a second pivotal trial, which Endo initiated promptly. Endo hoped to file its supplement to the NDA during 2002.

2000-01-01·Journal of Pain and Symptom Management2区 · 医学

Morphine with Dextromethorphan

2区 · 医学

Article

作者: Chevlen, E

MorphiDex, a 1:1 combination of dextromethorphan and morphine, provides satisfactory pain control at a significantly lower morphine daily dose. To determine the appropriate conversion regimens from other oral or transdermal opioid analgesics to MorphiDex (MS:DM), 592 patients with moderate to severe chronic pain requiring daily use of opioid analgesics were enrolled in this multicenter, open-label study. Patients were instructed to use MS:DM as needed to achieve satisfactory pain control. Overall, study patients took a significantly lower morphine daily dose (P = 0.0001), and a higher percentage (P = 0.0001) rated therapy with MS:DM as "very good" or "excellent" compared to their prestudy opioid. The mean daily dose of MS:DM remained level throughout a 10 month study extension period, suggesting that MS:DM may inhibit the development of tolerance to morphine. Most of the adverse events observed with MS:DM were those commonly reported with opioid therapy and were mild to moderate in severity. MS:DM appears safe and effective in treating moderate to severe chronic pain.

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