Duloxetine (Page 12 of 15)

14.6 Chronic Musculoskeletal Pain in Adults

Duloxetine delayed-release capsules are indicated for the treatment of chronic musculoskeletal pain in adults. This has been established in trials in adult patients with chronic low back pain and chronic pain due to osteoarthritis.

Trialsin Chronic Low Back Painin Adults

The efficacy of duloxetine delayed-release capsules in chronic low back pain (CLBP) in adults was assessed in two double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Studies CLBP-1 and CLBP-2), and one of 12-weeks duration (CLBP-3). Studies CLBP-1 and CLBP-3 demonstrated efficacy of duloxetine delayed-release capsules in the treatment of CLBP. Patients in all trials had no signs of radiculopathy or spinal stenosis.

Study CLBP-1: Two hundred thirty-six adult patients (N=115 on duloxetine delayed-release capsules, N=121 on placebo) enrolled and 182 (77%) completed 13-week treatment phase. After 7 weeks of treatment, duloxetine-treated patients with less than 30% reduction in average daily pain and who were able to tolerate 60 mg once daily had their duloxetine delayed-release capsules dosage, in a double-blinded fashion, increased to 120 mg once daily for the remainder of the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking duloxetine delayed-release capsules 60 mg to 120 mg daily had a significantly greater pain reduction compared to patients taking placebo. Randomization was stratified by the patients’ baseline NSAIDs use status. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use.

Study CLBP-2: Four hundred and four patients were randomized to receive fixed dosages of duloxetine delayed-release capsules daily or a matching placebo (N=59 on duloxetine delayed-release capsules 20 mg, N=116 on duloxetine delayed-release capsules 60 mg, N=112 on duloxetine delayed-release capsules 120 mg, N=117 on placebo) and 267 (66%) completed the entire 13-week trial. After 13 weeks of treatment, none of the three duloxetine delayed-release capsules dosages showed a statistically significant difference in pain reduction compared to placebo.

Study CLBP-3: Four hundred and one patients were randomized to receive fixed doses of duloxetine delayed-release capsules 60 mg daily or placebo (N=198 on duloxetine delayed-release capsules, N=203 on placebo), and 303 (76%) completed the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 12 weeks of treatment, patients taking duloxetine delayed-release capsules 60 mg daily had significantly greater pain reduction compared to patients taking placebo.

For various degrees of improvement in pain from baseline to study endpoint, Figures 8 and 9 show the fraction of patients in Studies CLBP-1 and CLBP-3 achieving that degree of improvement, respectively. The figures are cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned the value of 0% improvement.

Figure 8: Percentage of Adult Patients with CLBP Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study CLBP-1)

figure8
(click image for full-size original)

Figure 9: Percentage of Adult Patients with CLBP Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study CLBP-3)

figure9
(click image for full-size original)

Trialsin Chronic Pain Due to Osteoarthritis in Adults

The efficacy of duloxetine delayed-release capsules in chronic pain due to osteoarthritis (OA) in adults was assessed in 2 double-blind, placebo-controlled, randomized clinical trials of 13-weeks duration (Study OA-1 and Study OA-2). All patients in both trials fulfilled the ACR clinical and radiographic criteria for classification of idiopathic OA of the knee. Randomization was stratified by the patients’ baseline NSAIDs-use status.

Patients assigned to duloxetine delayed-release capsules started treatment in both trials at a dose of 30 mg once daily for one week. After the first week, the dose of duloxetine delayed-release capsules was increased to 60 mg once daily. After 7 weeks of treatment with duloxetine delayed-release capsules 60 mg once daily, in Study OA-1 patients with sub-optimal response to treatment (less than 30% pain reduction) and tolerated duloxetine delayed-release capsules 60 mg once daily had their doseincreased to 120 mg. However, in Study OA-2, all patients, regardless of their response to treatment after 7 weeks, were re-randomized to either continue receiving duloxetine delayed-release capsules 60 mg once daily or have their dosage increased to 120 mg once daily for the remainder of the trial. Patients in the placebo treatment groups in both trials received a matching placebo for the entire duration of trials. For both trials, efficacy analyses were conducted using 13-week data from the combined duloxetine delayed-release capsules 60 mg and 120 mg once daily treatment groups compared to the placebo group.

Study OA-1: Two hundred fifty-six patients (N=128 on duloxetine delayed-release capsules, N=128 on placebo) enrolled and 204 (80%) completed the trial. Patients had a mean baseline pain rating of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking duloxetine delayed-release capsules had significantly greater pain reduction than patients taking placebo. Subgroup analyses did not indicate that there were differences in treatment outcomes as a function of NSAIDs use.

Study OA-2: Two hundred thirty-one patients (N=111 on duloxetine delayed-release capsules, N=120 on placebo) enrolled and 173 (75%) completed the trial. Patients had a mean baseline pain of 6 on a numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). After 13 weeks of treatment, patients taking duloxetine delayed-release capsules did not show a significantly greater pain reduction than patients taking placebo.

In Study OA-1, for various degrees of improvement in pain from baseline to study endpoint, Figure 10 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the trial were assigned the value of 0% improvement.

Figure 10: Percentage of Adult Patients with OA Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity (Study OA-1)

figure10
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations:

Features

Strengths

20 mg a

30 mg a

40 mg a

60 mg a

Body color

White

Blue

Pink

White

Cap color

Blue

Blue

Blue

Blue

Cap imprint

ap

ap

ap

ap

Body imprint

DLX20

DLX30

DLX40

DLX60

Presentations and NDC Codes

Bottles of 30’s pack

76420-633-30

(repackaged from NDC 27241-097-xx)

76420-634-30

(repackaged from NDC 27241-098-xx)

76420-636-30

(repackaged from NDC 27241-164-xx)

76420-623-30

(repackaged from NDC 27241-099-xx)

Bottles of 60’s pack

76420-633-60

(repackaged from NDC 27241-097-xx)

76420-634-60

(repackaged from NDC 27241-098-xx)

Not Applicable

76420-623-60

(repackaged from NDC 27241-099-xx)

Bottles of 90’s pack

76420-633-90

(repackaged from NDC 27241-097-xx)

76420-634-90

(repackaged from NDC 27241-098-xx)

76420-636-90

(repackaged from NDC 27241-164-xx)

76420-623-90

(repackaged from NDC 27241-099-xx)

Bottles of 100’s pack

76420-633-01

(repackaged from NDC 27241-097-xx)

76420-634-01

(repackaged from NDC 27241-098-xx)

76420-636-01

(repackaged from NDC 27241-164-xx)

76420-623-01

(repackaged from NDC 27241-099-xx)

a equivalent to duloxetine base

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