Merck's Experimental -2 Inhibitor (Arcoxia) Performs as Well as Indomethacin for Gouty Arthritis

[Guest guest]

Merck's Arcoxia Performs as Well as Standard Therapy for Gouty Arthritishttp://www.medscape.com/viewarticle/451102?mpid=11371

WASHINGTON (Reuters Health) Mar 20 - Results of a new study show that treatment with Merck & Company Inc.'s experimental COX-2 inhibitor Arcoxia (etoricoxib) is effective for relieving pain in acute gouty arthritis, corporate researchers said on Thursday.

"In the study, Arcoxia 120 mg once daily provided effective relief from pain and inflammation comparable with indomethacin, which has been a standard therapy for this condition for more than 30 years," said Dr. Geba, the lead investigator and senior director of clinical development at Merck.

Researchers presented the results from the latest corporate-sponsored study at the 22nd Annual Scientific Meeting of the American Pain Society in Chicago.

According to the firm, patients on Arcoxia continued to report the same degree of reduction in joint pain as patients taking indomethacin over the entire 7-day study treatment period. Fewer patients on Arcoxia (4.%) also discontinued treatment due to lack of efficacy than patients on indomethacin (8.%), the company said.

A total of 189 patients participated in the randomized, double-blinded assessment. Patients were randomized to either once-a-day treatment with Arcoxia 120 mg or indomethacin 50 mg administered three times a day.

Patients completed assessments at baseline and on days one, two, five and eight as well as a final assessment 14 days after the last dose was administered on day eight. The primary endpoint was the patient assessment of joint pain over the first four days of treatment.

Merck said the prospective endpoint showed a comparable decrease in pain between days two through five with patients on Arcoxia reporting a 1.79 unit decrease from baseline on the patient assessment versus a 1.71 unit decrease for indomethacin. These results were comparable to those of a similar study reported a June 2002 issue of the British Medical Journal, the company said.

Arcoxia is a follow-up to Merck's blockbuster COX-2 inhibitor Vioxx (rofecoxib). The company believes Arcoxia inhibits the COX-2 enzyme with a higher specificity than existing COX-2 drugs and could give it a leg up in the multi-billion dollar a year worldwide arthritis therapy market.

The compound currently is in clinical trials for a range of indications, including osteoarthritis, rheumatoid arthritis, chronic pain, acute pain, menstrual pain, acute gouty arthritis and ankylosing spondylitis.

Merck initially filed for U.S. Food and Drug Administration (FDA) approval of Arcoxia in October 2001, but withdrew the application just months later, leading to speculation that the firm may have been concerned about the drug's safety profile.

Merck spokesman Loder told Reuters Health the drugmaker is planning to refile the U.S. approval application sometime by mid-2003.

He denied that the initial application was withdrawn due to safety concerns. Instead, he said Merck withdrew the application to submit a new application with clinical data for a wider range of indications.