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Curr Opin Investig Drugs. 2002 Mar;3(3):459-62.

EN-3231. Endo Pharmaceuticals.

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Vernalis Research Ltd, Winnersh, Wokingham, UK.


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.

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