Research & Development
Cumberland unveils new Caldolor in pre-mixed, ready-to-use bag to help address US opioid crisis
8 January 2020 -

Pharmaceutical company Cumberland Pharmaceuticals Inc (NASDAQ:CPIX) reported on Tuesday the availability of Caldolor (ibuprofen) Injection in ready-to-use bag containing 800 mg of ibuprofen in 200 ml patented low sodium formulation for injection for pain relief, in the US.

Caldolor launch follows the US FDA approval in 2019 of the product's new delivery method. It is the first and only FDA-approved pre-mixed bag of ibuprofen. Caldolor is a non-steroidal anti-inflammatory drug (NSAID) that may be used as the sole method of treatment for mild-moderate pain or as part of a multi-modal treatment for severe pain, according to the company.

In addition, the new, premixed presentation of Caldolor provides healthcare professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption. Even short-term opioid use after surgery can lead to long-term addiction. Prompt and appropriate pain management is vital to mitigating opioid use, revealed the company.

The published data for Caldolor supports administration just prior to surgery and throughout the postoperative period. As a result patients experience significantly less pain upon awakening, then remain in significantly less pain, while reducing their opioid consumption. Caldolor possesses three key therapeutic properties: anti-inflammatory, analgesic and antipyretic action, reported the company.

Also, Caldolor is available in 800 mg/8ml single–dose vial (100mg/ml) for dilution in addition to the ready-to-use bag (4 mg/ml), said the company.

Recently, the company has completed a clinical study for the use of Caldolor in patients from birth to six months of age. The topline results from the newborn study are forthcoming and will add to the growing body of literature that supports the safety and efficacy of the product.



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