Rapid Onset of Action1*

Diener study design: A randomized, double-blind, double-dummy, multicenter, cross-over trial comparing the safety and efficacy of 50 mg diclofenac potassium sachets (n=291), 50 mg diclofenac potassium tablets (n=298), and placebo (n=299) in patients with migraine pain.

DSK_RapidOnset

Diener Study1

CAMBIA delivered onset of analgesic effect in 15 minutes compared to 60 minutes for diclofenac potassium immediate-release tablets.1

*Time to onset of analgesic effect was defined as the first point at which there was a statistically significant difference on the visual analogue scale as compared to placebo. In patients treated with CAMBIA, this was 15 minutes (P≤.05 versus placebo); in patients treated with diclofenac tablets, this was 60 minutes (P≤.05 versus placebo).1

Analgesic effect based on time point to first statistically significant difference in visual analogue scale score or pain intensity score of active therapy over placebo for headache intensity.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (CONTINUED)
Hepatotoxicity
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue CAMBIA immediately, and perform a clinical evaluation of the patient.

To minimize the potential risk for an adverse liver-related event in patients treated with CAMBIA, use the lowest effective dose for the shortest duration possible.

Low Migraine Recurrence1‡

Diener study design: A randomized, double-blind, double-dummy, multicenter, cross-over trial comparing the safety and efficacy of 50 mg diclofenac potassium sachets (n=291), 50 mg diclofenac potassium tablets (n=298), and placebo (n=299) in patients with migraine pain.

Low Recurrence

Diener Study1

CAMBIA demonstrated low headache recurrence rates at 48 hours.1

15.5% of patients treated with CAMBIA experienced a recurrence of attack within 48 hours after attack resolution compared to 21.1% of patients treated with placebo and 21.8% of patients treated with diclofenac potassium immediate-release tablets.1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (CONTINUED)
Hypertension
NSAIDs, including CAMBIA, can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use NSAIDs, including CAMBIA, with caution in patients with hypertension. Monitor blood pressure closely during the initiation of NSAID treatment and throughout the course of therapy.

Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Sustained Pain-Free2

Diener study design: A randomized, double-blind, double-dummy, multicenter, cross-over trial comparing the safety and efficacy of 50 mg diclofenac potassium sachets (n=291), 50 mg diclofenac potassium tablets (n=298), and placebo (n=299) in patients with migraine pain.

Lipton study design: Phase III, prospective, randomized, double-blind, parallel-group, single-dose, placebo-controlled, multicenter, safety and efficacy study assessing the efficacy of diclofenac potassium 50 mg (n=343) for oral solution vs placebo (n=347) for the treatment of migraine pain.

Long Lasting

CAMBIA provided a 24-hour sustained pain-free response.2

 

As a secondary endpoint, the proportion of patients who sustained pain-free response, defined as the percentage of patients who reported no pain at 2 hours without the use of rescue medication or recurrence of pain for up to 24 hours post treatment, was also evaluated.2

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (CONTINUED)
Heart Failure and Edema
A meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

Avoid the use of CAMBIA in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If CAMBIA is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Functionality3

Lipton study design: Phase III, prospective, randomized, double-blind, parallel-group, single-dose, placebo-controlled, multicenter, safety and efficacy study assessing the efficacy of diclofenac potassium 50 mg (n=343) for oral solution vs placebo (n=347) for the treatment of migraine pain.

DSK_RestoredFunction

Lipton Study3

At 2 hours, CAMBIA restored function in twice as many patients as compared to those taking placebo.3

As a secondary endpoint, restoration of function, defined as the percent of patients who reported being able to return to routine activities, was also evaluated.3

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS (CONTINUED)
Renal Toxicity and Hyperkalemia
Renal Toxicity
Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CAMBIA in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.

Anaphylactic Reactions
Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.

References

1. Diener HC, Montagna P, Gács G, et al. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia. 2006;26(5):537-547. 2. CAMBIA [package insert]. Newark, CA: Depomed, Inc; 2016. 3. Lipton RB, Grosberg B, Singer RP, et al. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia. 2010;30(11):1336-1345.