Depomed Announces New CAMBIA® Formulation

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 USAGECAMBIA ® (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 ADMINISTRATIONUse 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 DiclofenacDifferent 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.

CONTRAINDICATIONSCAMBIA 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 EventsClinical 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.

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