Arcoxia

[Guest guest]

Hi Jeanetta,

This is what I found so far.

Merck plans to refile NDA for Arcoxia

[Published 13 June 2002 Source Espicom Business Intelligence]

Merck & Co plans to refile an expanded NDA for Arcoxia (etoricoxib) with the FDA

in the second half of 2003. The company has been in ongoing discussions with the

FDA since the withdrawal of the original NDA for Arcoxia on 15th March. In a

recent meeting, the FDA requested additional data on the acute pain indications

for Arcoxia and additional cardiovascular safety data for Arcoxia versus

comparators other then naproxen.

In order to enhance its filing for a broad range of acute pain indications,

including gout, Merck will provide data from several ongoing studies on Arcoxia

in acute pain. In response to the FDA's request for additional data on the

cardiovascular safety of Arcoxia, Merck will soon be enrolling patients in a

large clinical trial comparing Arcoxia to a non-naproxen non-steroidal

anti-inflammatory drug. Both gastrointestinal and cardiovascular safety data

will be collected in this study. As previously announced, Merck will be

submitting additional efficacy data to support a new indication for ankylosing

spondylitis. Merck will also seek indications for osteoarthritis, rheumatoid

arthritis, chronic pain, acute pain, dysmenorrhoea and acute gouty arthritis.

Arcoxia has been approved for use in Mexico, Brazil, Peru and the UK. Merck

expects to receive regulatory approval of the drug in other European countries

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