Merck's resubmission of its COX-2 inhibitor Arcoxia (etoricoxib) seeks a narrowed indication for treatment of osteoarthritis only, the company announced Nov. 10.

The company is requesting approval in that indication for 30 mg and 60 mg once-daily dosage strengths of the follow-on to the firm's withdrawn Vioxx (rofecoxib). Merck submitted a separate NDA for the 30 mg strength in April 2004, while the 60 mg formulation was filed in the original December 2003 Arcoxia NDA.

The company said it anticipates a six-month review, with a decision at the end of April 2007, suggesting a complete response was submitted to FDA in late October.

While etoricoxib is approved outside the U.S. in a 90 mg dose for osteoarthritis and other indications, "it is appropriate only to seek approval for the dosages that are being recommended for use to treat [osteoarthritis]" in the U.S., Merck told "The Pink Sheet" DAILY.

The company originally submitted Arcoxia for indications in osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea, acute gouty arthritis and ankylosing spondylitis.

FDA requested additional safety and efficacy data for etoricoxib in an October 2004 approvable letter (¹ Also see "Merck’s Arcoxia “Approvable” At FDA" - Pink Sheet, 29 October, 2004.).

Merck said its response includes results from the Multinational Etoricoxib and Diclofenac Arthritis Long-Term Program (MEDAL), adding that the data will be made public Nov. 13 in a peer-reviewed journal and at meetings of the American College of Rheumatology and the American Heart Association.

The MEDAL program includes three studies - MEDAL, EDGE and EDGE I - comparing Arcoxia to the non-steroidal anti-inflammatory drug diclofenac. The cardiac safety study MEDAL, which began in 2002, includes data from more than 23,000 osteoarthritis and rheumatoid arthritis patients.

Merck submitted preliminary analysis from the study to FDA in August showing that Arcoxia was non-inferior to diclofenac (² Also see "Merck’s Vioxx Successor Arcoxia May Be Closer To Market" - Pink Sheet, 23 August, 2006.). The data showed that the 90 mg dose of Arcoxia had a higher incidence of discontinuation due to edema-related adverse events and congestive heart failure.

Merck said it "is continuing its efforts with respect to other doses and indications to support subsequent U.S. supplemental NDAs."

The company withdrew Vioxx from the market in September 2004 due to cardiovascular adverse events (³ [A#14040930002]).

Earlier this week, Novartis said it plans to resubmit its COX-2 inhibitor Prexige (lumiracoxib) following the drug's approval in the European Union and Canada for treatment of osteoarthritis (⁴ Also see "Novartis Will Resubmit COX-2 Inhibitor In The U.S. In 2007" - Pink Sheet, 7 November, 2006.).

-Shirley Haley (s.haley@elsevier.com)

Merck Seeks Narrowed Arcoxia Indication In Response To “Approvable” Letter

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