Figure 2 shows the cumulative percentages of patients from each treatment group who had attained at least the measure of improvement in SIB score shown on the X axis. The curves show that both patients assigned to NAMENDA XR 28 mg/AChEI and placebo/AChEI have a wide range of responses, but that the NAMENDA XR 28 mg/AChEI group is more likely to show an improvement or a smaller decline.

Figure 2: Cumulative percentage of patients completing 24 weeks of double-blind treatment with specified changes from baseline in SIB scores.

Figure 3 shows the time course for the CIBIC-Plus score for patients in the two treatment groups completing the 24 weeks of the study. At 24 weeks of treatment, the mean difference in the CIBIC-Plus scores for the NAMENDA XR 28 mg/AChEI-treated patients compared to the patients on placebo/AChEI was 0.3 units. Using an LOCF analysis, NAMENDA XR 28 mg/AChEI treatment was statistically significantly superior to placebo/AChEI.

Figure 3: Time course of the CIBIC-Plus score for patients completing 24 weeks of treatment.

Figure 4 is a histogram of the percentage distribution of CIBIC-Plus scores attained by patients assigned to each of the treatment groups who completed 24 weeks of treatment.

Figure 4: Distribution of CIBIC-Plus ratings at week 24

16 HOW SUPPLIED/STORAGE AND HANDLING

7 mg Capsule:

Yellow opaque capsule, with “FLI 7 mg” black imprint.

Bottle of 30: NDC# 0456-3407-33

14 mg Capsule:

Yellow cap and dark green opaque capsule with “FLI 14 mg” black imprint on the yellow cap.

Bottle of 30: NDC# 0456-3414-33
Bottle of 90: NDC# 0456-3414-90
10 x 10 Unit Dose: NDC# 0456-3414-63

21 mg Capsule:

White to off-white cap and dark green opaque capsule, with “FLI 21 mg” black imprint on the white to off-white cap.

Bottle of 30: NDC# 0456-3421-33

28 mg Capsule:

Dark green opaque capsule, with “FLI 28 mg” white imprint.

Bottle of 30: NDC# 0456-3428-33
Bottle of 90: NDC# 0456-3428-90
10 x 10 Unit Dose: NDC# 0456-3428-63

Titration Pack: NDC# 0456-3400-29
                           Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg)

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling.

To assure safe and effective use of NAMENDA XR, the information and instructions provided in the patient information section should be discussed with patients and caregivers.

Patients and caregivers should be instructed to take NAMENDA XR only once per day, as prescribed.

Patients and caregivers should be instructed that NAMENDA XR capsules be swallowed whole. Alternatively, NAMENDA XR capsules may be opened and sprinkled on applesauce and the entire contents should be consumed. The capsules should not be divided, chewed or crushed.

Patients and caregivers should be advised that the product may cause headache, diarrhea and dizziness.

Manufactured for:Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045

Manufactured by:
Forest Laboratories Ireland Ltd

Licensed from Merz Pharmaceutic