Message from CEO

To our Shareholders, Employees and Partners:

I am very pleased to announce that the national launch of our FDA-approved Next Generation Caldolor product!
 
Caldolor was originally approved in a vial presentation. The new formulation of Caldolor comes in a ready-to-use, pre-mixed bag containing 800 mg of ibuprofen in a patented formulation. This new presentation will provide healthcare professionals with a formulation that is ready to use and easy to administer. It’s the first and only FDA-approved pre-mixed bag of ready-to-use, injectable ibuprofen.
 
In 2019, we commenced a “soft launch” of the product, given an initial limited supply. We embarked upon the soft launch by first introducing the new product to a group of key hospitals across the country, while awaiting the larger quantities of product inventory to support full national distribution. The information we gained has proven helpful in refining our marketing, promotional and distribution strategy for the brand.
 
The misuse of and growing addiction to opioids is a national crisis. As we all know, the opioid crisis in America is a public health emergency. And every day, over 130 Americans die of an opioid overdose, according to The Centers for Disease Control and Prevention.
 
There is a growing body of literature demonstrating that use of Caldolor in hospitals can significantly decrease both surgical pain and the need for opioids in the patients who receive it. Administering Caldolor just prior to surgery, during surgery and throughout the postoperative period, has resulted in patients experiencing significantly less pain immediately after surgery, remaining in less pain afterwards, and subsequently reducing the patients’ need for opioids.
 
Clinical studies of Caldolor demonstrate:

  • Up to a 58% reduction in opioid use compared to placebo group
  • Up to a 43% reduction in VAS scores at rest compared to opioids alone
  • Patients reporting significantly less pain shortly after waking
  • Patients remain in significantly less pain during recovery
  • Potential to improve quality of recovery and reduce postsurgical fatigue
  • Significant pain and fever reduction in children ages six months and older

 
On the clinical front, we embarked on a pediatric clinical program and expanded the product’s label receiving FDA approval for Caldolor’s use in children and teens. We have also completed a clinical study evaluating this important product in newborns. Our Caldolor clinical studies have involved nearly 2,000 patients resulting in an outstanding safety data base. We are planning to further expand the product’s labeling based on this wealth of new data.
 
I’d like to acknowledge and thank our team for their dedicated efforts thus far in 2020. We are well positioned to build upon the positive momentum we generated in 2019. We remain focused on our mission of advancing patient care through the delivery of high-quality pharmaceutical products, and we look forward to keeping you updated as the year progresses.
 
All the best,

A.J. Kazimi
Chief Executive Officer

January 2020
 

For full prescribing information, including boxed warning, visit www.caldolor.com.