Serum Uric Acid Level less than 6 mg per dL at Final Visit: ULORIC 80 mg was superior to allopurinol in lowering serum uric acid to less than 6 mg per dL at the final visit. ULORIC 40 mg daily, although not superior to allopurinol, was effective in lowering serum uric acid to less than 6 mg per dL at the final visit (Table 3).

Table 3: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL at Final Visit 
     Difference in Proportion
(95% CI)
Study* ULORIC
40 mg daily ULORIC
80 mg daily allopurinol Placebo ULORIC 40 mg
vs
allopurinol ULORIC 80 mg
vs
allopurinol
*
Randomization was balanced between treatment groups, except in Study 2 in which twice as many patients were randomized to each of the active treatment groups compared to placebo.
Study 1
(6 months)
(N=2268) 45% 67% 42%  3%
(-2%, 8%) 25%
(20%, 30%)
Study 2
(6 months)
(N=643)  72% 39% 1%  33%
(26%, 42%)
Study 3
(12 months)
(N=491)  74% 36%   38%
(30%, 46%)
Randomization was balanced between treatment groups, except in Study 2 in which twice as many patients were randomized to each of the active treatment groups compared to placebo.
Study 1
(6 months)
(N=2268) 45% 67% 42%  3%
(-2%, 8%) 25%
(20%, 30%)
Study 2
(6 months)
(N=643)  72% 39% 1%  33%
(26%, 42%)
Study 3
(12 months)
(N=491)  74% 36%   38%
(30%, 46%)

In 76% of ULORIC 80 mg patients, reduction in serum uric acid levels to less than 6 mg per dL was noted by the Week 2 visit. Average serum uric acid levels were maintained at 6 mg per dL or below throughout treatment in 83% of these patients.

In all treatment groups, fewer subjects with higher baseline serum urate levels (≥ 10 mg per dL) and/or tophi achieved the goal of lowering serum uric acid to less than 6 mg per dL at the final visit; however, a higher proportion achieved a serum uric acid less than 6 mg per dL with ULORIC 80 mg than with ULORIC 40 mg or allopurinol.

Study 1 eva luated efficacy in patients with mild to moderate renal impairment (i.e., baseline estimated Clcr less than 90 mL per minute). The results in this sub-group of patients are shown in Table 4.

Table 4: Proportion of Patients with Serum Uric Acid Levels Less Than 6 mg per dL in Patients with Mild or Moderate Renal Impairment at Final Visit 
   Difference in Proportion
(95% CI)
ULORIC
40 mg daily
(N=479) ULORIC
80 mg daily
(N=503) allopurinol*
300 mg daily
(N=501) ULORIC 40 mg vs allopurinol ULORIC 80 mg vs allopurinol
*
Allopurinol patients (n=145) with estimated Clcr ≥ 30 mL per min and Clcr ≤ 59 mL per min were dosed at 200 mg daily.
50% 72% 42% 7%
(1%, 14%) 29%
(23%, 35%)

16 HOW SUPPLIED/STORAGE AND HANDLING
ULORIC 80 mg tablets are light green to green in color, teardrop shaped, debossed with "TAP" on one side and "80" on the other side and supplied as:

NDC Number Size
21695-516-30 Bottle of 30 Tablets

Protect from light. Store at 25°C (77°F); excursions permitted to 15°– 30°C (59°– 86°F) [See USP Controlled