Depomed (DEPO) Debuts New CAMBIA Formulation; Includes Sucralose Sweetener

November 4, 2016 8:01 AM EDT

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Depomed Inc. (Nasdaq: DEPO) 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.



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