NEWARK, Calif., Nov. 04, 2016 (GLOBE NEWSWIRE) -- Depomed Inc. (NASDAQ:DEPO) today announced the introduction of a new formulation of CAMBIA® (diclofenac potassium) for oral solution, that contains the sweetener sucralose, replacing the sweeteners saccharin sodium and aspartame. The new formulation, which was approved by the U.S. Food and Drug Administration, addresses some patient sensitivities towards certain sweeteners and is not as a result of any product safety concerns nor does it alter the efficacy profile of the product. CAMBIA® with sucralose will be available following the dispensing of current inventories containing aspartame.
CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
“Recognizing that some patients may have sensitivities to aspartame, CAMBIA’s new formulation is a welcome addition to the migraine treatment arsenal,” said Alan Rapoport, M.D., Clinical Professor of Neurology at The David Geffen School of Medicine at UCLA, Los Angeles, California, and Immediate Past-President of the International Headache Society. “With this proactive step, Depomed continues their commitment to partnering with the medical community.”
“CAMBIA’s new formulation is aimed at improving the patient experience,” said Srinivas Rao, M.D., Ph.D., Chief Medical Officer of Depomed. “We are pleased to be offering this new formulation as it exemplifies Depomed’s collaborative approach with physicians who are on the front line of treating patients with pain.”
With this reformulation, item 5.14 from the CAMBIA label titled Phenylketonurics which states “CAMBIA contains aspartame equivalent to phenylalanine 25 mg per packet.” is removed. Phenylketonuria (PKU) is an inherited metabolic disorder in which a person does not have the liver enzyme needed to break down phenylalanine.
INDICATIONS AND USAGE
CAMBIA® (diclofenac potassium) for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use:
- CAMBIA is not indicated for the prophylactic therapy of migraine.
- The safety and effectiveness of CAMBIA have not been established for cluster headache.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- CAMBIA is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk, Ulceration, and Perforation
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established.
Non-Interchangeability with Other Formulations of Diclofenac
Different formulations of oral diclofenac are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulation of diclofenac to CAMBIA.
CONTRAINDICATIONS
CAMBIA is contraindicated in the following patients:
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.
- In the setting of coronary artery bypass graft (CABG) surgery.
WARNINGS AND PRECAUTIONS
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
Post-MI Patients
Avoid the use of CAMBIA in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If CAMBIA is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
See full Prescribing Information for more information.
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.
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.
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.
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.
Exacerbation of Asthma Related to Aspirin Sensitivity
CAMBIA is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Serious Skin Reactions
NSAIDs, including diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events can occur without warning.
CAMBIA should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. CAMBIA is contraindicated in patients with previous serious skin reactions to NSAIDs.
Hematologic Toxicity
Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with CAMBIA has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including CAMBIA, may increase the risk of bleeding events. Concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), and serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients and any patient who may be adversely affected by alterations in platelet function for signs of bleeding.
ADVERSE REACTIONS
The most common adverse events (≥1% and greater than placebo) in clinical trials with CAMBIA were nausea and dizziness.
DRUG INTERACTIONS
Drugs That Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs):
Monitor patients for bleeding who are concomitantly taking CAMBIA with drugs that interfere with hemostasis. Concomitant use of CAMBIA and analgesic doses of aspirin is not generally recommended.
ACE Inhibitors and ARBs
Concomitant use with CAMBIA in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.
Diuretics
NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Digoxin
Concomitant use with CAMBIA can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.
Please see full Prescribing Information for complete information about Drug Interactions.
USE IN SPECIFIC POPULATIONS
Use in Pregnancy
Based on animal data, may cause fetal harm. Based on human data, starting at 30 weeks gestation, CAMBIA should be avoided as premature closure of the ductus arteriosus in the fetus may occur. Prior to 30 weeks gestation, CAMBIA should be used in pregnancy only if the potential benefit outweighs the risk to the fetus (Category C). Starting at 30 weeks, CAMBIA can cause fetal harm (Category D).
Nursing Mothers:
Use with caution, as it is not known if diclofenac is excreted in human milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects
Hepatic Impairment
Because hepatic metabolism accounts for almost 100% of diclofenac elimination, patients with hepatic impairment should be considered for treatment with CAMBIA only if the benefits outweigh the risks.
Renal Impairment
Treatment with CAMBIA is not recommended in patients with advanced renal disease.
Please see accompanying full Prescribing Information and Medication Guide for more information about CAMBIA.
About Depomed
Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit www.depomed.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to risks detailed in the Company’s Securities and Exchange Commission filings, including the Company’s most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the Company’s plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.