EN-3231. Endo Pharmaceuticals.

Abstract

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.

• Authors: Nat Monck
• Journal: Current opinion in investigational drugs (London, England : 2000) (Curr Opin Investig Drugs) Vol. 3 Issue 3 Pg. 459-62 (Mar 2002) ISSN: 1472-4472 [Print] England
• PMID: 12054097 (Publication Type: Journal Article)

Chemical References

• Analgesics, Opioid
• Drug Combinations
• EN 3231
• Dextromethorphan
• Morphine

Topics

• Analgesics, Opioid (adverse effects, chemical synthesis, metabolism, pharmacology, therapeutic use, toxicity)
• Animals
• Clinical Trials, Phase II as Topic
• Clinical Trials, Phase III as Topic
• Contraindications
• Dextromethorphan (chemical synthesis, metabolism, pharmacology, therapeutic use)
• Drug Combinations
• Humans
• Morphine (chemical synthesis, metabolism, pharmacology, therapeutic use)
• Pain (drug therapy)
• Structure-Activity Relationship