Elan met FDA to clear way for ziconotide drug

Elan corporation, the Athlone-based pharmaceutical company, has had a pre-new drug application meeting (NDA) with the US Food…

Elan corporation, the Athlone-based pharmaceutical company, has had a pre-new drug application meeting (NDA) with the US Food and Drug Administration (FDA) for its ziconotide drug. The drug is used for the treatment of chronic neuropathic and malignant pain.

The statement is designed to erase some of the confusion in the market about ziconotide, which is expected to provide Elan with substantial benefits.

Elan said the meeting aimed to gain marketing approval for the product in the shortest possible time. It has agreed several points with the FDA including additional open-label clinical studies. Elan believes an NDA submission should be made towards the end of the year, and if approved, the product should be available in the middle of next year.

US analysts see substantial scope for the new drug. Some have suggested it has a potential to generate $250 million (€373 million) to $300 million (€448 million) per annum. If it proves to be a success, it could reach its full potential three years after introduction, said Elan's finance director, Mr Tom Lynch.

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Elan noted that in two pivotal studies conducted in patients who failed, or were intolerant of opioid treatment, ziconotide "showed a significant reduction in pain compared to placebo".

Mr Lynch also confirmed that the dispute with Fuisz Technologies, a US pharmaceutical company, has been settled and Fuisz has withdrawn its action.