title: 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.affiliation: Vernalis Research Ltd, Winnersh, Wokingham, UK. n.monck@vernalis.com
authors.forename: Nat
authors.initials: N
authors.lastname: Monck
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects / Q000138:chemical synthesis / Q000378:metabolism / Q000494:pharmacology / Q000627:therapeutic use* / Q000633:toxicity; D000818:Animals; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D000075202:Contraindications; D003915:Dextromethorphan / Q000138:chemical synthesis / Q000378:metabolism / Q000494:pharmacology / Q000627:therapeutic use*; D004338:Drug Combinations; D006801:Humans; D009020:Morphine / Q000138:chemical synthesis / Q000378:metabolism / Q000494:pharmacology / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy*; D013329:Structure-Activity Relationship
chemical_list: D000701:Analgesics, Opioid; D004338:Drug Combinations; C468112:EN 3231; D003915:Dextromethorphan; D009020:Morphine