FDA Advisory Committee Reviews - June 2007

Topic. Clinical run system and endpoints for drugs for acute gout, including a accounting of NDA 21-389, Arcoxia (etoricoxib), Merck.
Prospect. The AAC reviewed clinical visitation designs and endpoints for drugs for acute gout, including NDA 21-389, Arcoxia (etoricoxib [ATC:M1A]), sponsored by Merck.
Etoricoxib is a NSAID, cyclo-oxygenase-2 (COX-2) inhibitor for the discussion of arthritic gout.
Acute gouty arthritis affects approximately 2.2 large indefinite quantity family line in the US annually.
It is one of the most common forms of inflammatory connexion disease in men over the age of 40.
Acute gouty arthritis is characterized by painful spliff burning caused by metabolic imbalances that issue in the overproduction or under waste matter of uric acid activity to deposits of uric acid crystals in the joints, especially in the lower extremities.
Acute gouty arthritis is associated with intense pain and excitement that can motion peak levels within a few work time and remain at that structure for several days.
The existence of gout is confirmed by the mien of polymorphonuclear leukocytes and intracellular monosodium urate crystals in synovial matter aspirated from an inflamed fag.
Monosodium urate crystals observed using polarized verve microscopy are needle-shaped and negatively birefringent (refracting light).
Self-examination of aspirated cigarette matter can also rule out other disorders, such as septic arthritis and pseudogout.
Occasionally, patients with gout may present tense without uric acid crystals in the synovial substance aspirate.
However, dream repeated five work time to one day later shows crystals in the synovial substance of most of these patients.
The English language Arthritis Relation (ARA) outlined more medicinal drug criteria for the diagnosis of gout.
Currently, acute gout is managed by NSAIDs, colchicine, and corticosteroid therapy.
The FDA is hunt entropy from experts in investigation and purpose in guild to develop direction on the clinical territorial dominion of new therapies for gout.Proposed IndicationEtoricoxib is .indicated for the pain and signs of inflammations associated with acute gouty arthritis.Proposed Dose120 mg of etoricoxib once daily
The citizens committee was generally supportive of the clinical tribulation blueprint used for etoricoxib and agreed that placebo-controlled trials would be difficult in acute gout due to the ethical considerations of deduction effective idiom.
While acknowledging considerations related to enrolment difficulties, such as limited disease settlement, the administrative body recommended increasing the duration of clinical trials from 8 days to several weeks in idiom to good demonstrate efficacy.
The citizens committee indicated that pain as a pinion endpoint in acute gout trials is appropriate and recommended the use of patient-determined pain scales.
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