NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists), κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor agonists(Mu opioid receptor agonists)

Therapeutic Areas

Nervous System Diseases

Active Indication-

Inactive Indication

Cancer Pain

Originator Organization

Endo International Plc

Active Organization-

Inactive Organization

Endo Pharmaceuticals, Inc.

Endo International Plc

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC70H92Br2N4O12S

InChIKeyYBBSRIKLZJRAOV-CICACRMTSA-N

CAS Registry350049-07-9

100 Clinical Results associated with Dextromethorphan/Morphine

100 Translational Medicine associated with Dextromethorphan/Morphine

100 Patents (Medical) associated with Dextromethorphan/Morphine

Literatures (Medical) associated with Dextromethorphan/Morphine

01 Jan 2007·The Journal of PainQ2 · MEDICINE

Placebo-Controlled Comparison of a Morphine/Dextromethorphan Combination With Morphine on Experimental Pain and Hyperalgesia in Healthy Volunteers

Q2 · MEDICINE

Article

Author: Michael C. Rowbotham ; Adam R. Frymoyer ; Karin Lottrup Petersen

In this double-blind, placebo-controlled, crossover study we compared the analgesic effect of a single oral dose of 30-mg dextromethorphan and 30-mg morphine combination (MS/DM) to 30 mg morphine (MS) alone and either placebo or 30 mg dextromethorphan (DM) on cutaneous sensitization induced by heat/capsaicin (topical) sensitization on the forearm and the brief thermal sensitization model on the thigh in 22 healthy volunteers. Outcome measures were areas of secondary hyperalgesia to brush and von Frey hair stimulation in both sensitization models and the painfulness of acute thermal noxious stimulation on the upper arm. Compared with placebo, both MS/DM and morphine had some effect on the secondary hyperalgesia and reduced the painfulness of a noxious thermal stimulus. The analgesic effect of MS/DM was not superior to that of morphine on any outcome measure. These results differ from preclinical studies with animal experimental pain models in which DM markedly potentiated the analgesic effects of opioids, but they are in accordance with recent clinical trials for chronic pain.PERSPECTIVEAdding dextromethorphan to morphine (1:1 ratio) did not enhance analgesia on measures of experimental cutaneous sensitization and acute noxious thermal stimulation in healthy volunteers. The results differ from preclinical studies but agree with clinical trials. Human experimental models of pain and neuronal sensitization, which are responsive to oral opioids, allow efficient study of opioid combination analgesics and simplify the process for determining the optimal dose and/or dose ratio.

01 Jun 2005·PainQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

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

EN-3231. Endo Pharmaceuticals.

Article

Author: 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.

100 Deals associated with Dextromethorphan/Morphine

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	United States	Endo Pharmaceuticals, Inc.	-
Cancer Pain	Phase 3	-	Endo International Plc	-

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