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COX-2 INHIBITORS IN THE PIPELINE

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

COX-2 INHIBITORS IN THE PIPELINE



COX-2 INHIBITORS IN THE PIPELINE

Compiled by "The NDA Pipeline," www.ndapipeline.com

Company & Name

Indication

Phase

NOVEL COX-2 INHIBITORS IN DEVELOPMENT

Almirall Prodesfarma's (Spain) LAS-34475

Osteoarthritis

Phase II/III

GlaxoSmithKline's 406381

Acute and chronic pain

Phase II

Grupo Uriach's (Spain) cimicoxib (UR-8880)

Rheumatoid arthritis, OA, and pain

Phase II

Sankyo's CS-502

Pain and inflammation

Phase II

Abbott's ABT-963

Arthritis

Phase I

GlaxoSmithKline's 644784

Acute and chronic pain, arthritis, and schizophrenia

Phase I

Sankyo's CS-706 (R-109339)

Pain and inflammation

Phase I

NitroMed/Merck's nitric oxide-enhancing COX-2 inhibitors

Pain and inflammation

Preclinical

Pfizer's SC-236

Breast cancer

Preclinical

PENDING APPLICATIONS AND LINE EXTENSIONS FOR COX-2 INHIBITORS

Merck's Arcoxia (etoricoxib)

OA, RA, ankylosing spondylitis, chronic lower back pain, acute pain, dysmenorrhea, and acute gouty arthritis

NDA filed 12/30/2003

Pfizer's Dynastat (parecoxib)

Valdecoxib prodrug for acute pain

NDA "not approvable" 7/13/2001, trials have been completed to support a resubmission

Novartis' Prexige (lumiracoxib)

OA and acute pain

NDA "not approvable" 9/22/2003, clinical trials to support resubmission ongoing

Pfizer's Bextra (valdecoxib)

Migraine pain

sNDA submitted 11/2003

Pfizer's Bextra (valdecoxib)

Acute pain states

sNDA "not approvable" 2001, additional studies completed in 2004

Pfizer's Celebrex (celecoxib)

Prevention of esophageal cancer in Barrett's esophagus patients; skin cancer in actinic keratosis patients; recurrence of superficial bladder cancer; and prevention and treatment of breast cancer

Phase II/III

Pfizer's Celebrex (celecoxib)

Ankylosing spondylitis and chronic low back pain

Development

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