Carisoprodol (Page 4 of 5)

14 CLINICAL STUDIES

The safety and efficacy of carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposus, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., carisoprodol 250 mg, carisoprodol 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., carisoprodol 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.

The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the carisoprodol 250 mg and placebo groups in both studies.

The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.

Table 3. Results of the Primary Efficacy Endpointsa in Studies 1 and 2
a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).
b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the Carisoprodol 250 mg and placebo groups.
Study Parameter Placebo Carisoprodol 250 mg Carisoprodol 350 mg
Number of Patients n=269 n=264 n=273
Relief from Starting Backache, Mean (SE)b 1.4 (0.1) 1.8 (0.1) 1.8 (0.1)
1 Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI) 0.4 (0.2, 0.5) 0.4 (0.2, 0.6)
Global Impression of Change, Mean (SE)b 1.9 (0.1) 2.2 (0.1) 2.2 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI) 0.2 (0.1, 0.4) 0.3 (0.1, 0.4)
Number of Patients n=278 n=269
Relief from Starting Backache, Mean (SE)b 1.1 (0.1) 1.8 (0.1)
2 Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI) 0.7 (0.5, 0.9)
Global Impression of Change, Mean (SE)b 1.7 (0.1) 2.2 (0.1)
Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI) 0.5 (0.4, 0.7)

Patients treated with carisoprodol experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

16 HOW SUPPLIED/STORAGE AND HANDLING

350 mg Tablets: round, convex, white tablets, inscribed with 111 on one side and “O” on the other side; available in bottles of 100 (NDC 69584-111-10), bottles of 500 (NDC 69584-111-50) and bottles of 1000 (NDC 69584-111-90).

Storage
Store at controlled room temperature 20° — 25°C (68° — 77°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol.

Sedation
Advise patients that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].

Avoidance of Alcohol and Other CNS Depressants
Advise patients to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1)].

Carisoprodol Should Only Be Used for Short-Term Treatment
Advise patients that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Lactation
Advise nursing mothers using carisoprodol to monitor neonates for signs of sedation [see Use in Specific Populations (8.2)].

Oxford Pharmaceuticals, LLC
Birmingham, AL 35211
8200005
09/2019 REV00
© 2019 Oxford Pharmaceuticals, LLC

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