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Endo pain drug gets priority review

Endo Pharmaceuticals has been granted a priority review by the US Food and Drug Administration for a new formulation of its pain drug oxymorphone

Endo Pharmaceuticals has been granted a priority review by the US Food and Drug Administration (FDA) for a new formulation of its pain drug oxymorphone that is designed to prevent abuse.

The new tablet is made to resist crushing, breaking, powdering or pulverising.

Priority review, which is reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists, means that the FDA aims to act on a New Drug Application (NDA) within six months rather than the standard 10 to 12 months. The FDA has set January 7, 2011 as the action date for the Endo product.

This new formulation of the long-acting drug is a semi-synthetic opioid analgesic for treatment of moderate-to-severe chronic pain in patients requiring continuous pain relief over an extended period of time.

Endo has marketed oxymorphone in the US since 1959. It sells the drug under the brandnames Opana and Opana ER.

23rd September 2010

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