Vibativ was specifically designed to kill drug-resistant bacteria. Additionally, as A.J. mentioned, we are launching a new package for the product this quarter. This new presentation is designed for smaller accounts that either don’t have the space to store or don’t have the patient volume to necessitate the investment in larger quantities. Moving next to Kristalose. Our prescription strength laxative packaged in a convenient premeasured powdered dose that dissolves quickly in just 4 ounces of water for a clear, taste-free and grit-free solution. Kristalose continues to be our largest selling product and is benefiting nicely from the support of our 2 co-promotion partners. Moreover, we found that the brand performs best in the states where we have Medicaid coverage.
New York State recently added Kristalose to its Medicaid formulary and we are implementing a special initiative to increase our presence and share of voice in this market. We believe that this new coverage is contributing to the growth of the product. Shifting now to Caldolor, our intravenous ibuprofen product. As A.J. mentioned, we recently shared a special report evaluating the growing amount of data supporting the use of Caldolor as a standard of care for the treatment of pain and fever in adults, children and infants as young as 3 months of age. Takeaways from the special report include that intravenous ibuprofen results in significant reductions in temperature compared to placebo in adults and acetaminophen in pediatric patients. Also, administration of the product prior to surgery leads to patients waking up in significantly less postsurgical pain while also lessening or even eliminating the need for opioids.
The use of intravenous ibuprofen in the hospital emergency department for acute pain can also minimize opioid requirements while achieving significant pain control. Finally, Caldolor should be considered a foundation for any multimodal pain regimen. Pain management has become one of the most common health care problems in the United States. As this new report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control while minimizing the need for opioids, a non-steroidal anti-inflammatory drug such as Caldolor can provide a cornerstone for many treatment protocols, and we are encouraged by the substantial database emerging from our studies in patients of all ages. With its newly approved pediatric labeling, Caldolor is now the only non-opioid product approved to treat pain in infants that’s delivered via an injection.
The new indication was further supported by the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborns. We are very pleased to have further expanded the product labeling for use in patients of nearly all ages and have launched a marketing initiative highlighting this new indication. Additionally, we expect Caldolor will be eligible for special Medicare reimbursement under the new Non-Opioids Prevent Addiction in the Nation, NOPAIN legislation, which was enacted as part of the Consolidated Appropriations Act of 2023. The NOPAIN Act requires Medicare to provide separate and more favorable reimbursement for non-opioid products used to manage pain during surgeries conducted in both hospital outpatient departments, as well as ambulatory surgical centers.
This legislation applies in part to products that are indicated to provide analgesia without acting upon the body’s opioid receptors. As a result, we do expect that the NOPAIN Act will affect Medicare reimbursement for Caldolor. The CMS requested that manufacturers with potentially applicable non-opioid products, submit comments in supporting clinical evidence regarding products that could be eligible for separate payment. We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023, explaining why Caldolor should be included and separately reimbursed. We now await information from CMS regarding the reimbursement status and the pricing for the product. The act is scheduled to go into effect in early 2025 and will initially apply to products that are furnished between January 1, 2025, and January 1, 2028.
Moving on to Sancuso. A new facility was approved by the FDA, and we have completed the manufacturing of Cumberland package product there. We will be launching these new supplies of our Cumberland branded products this year. We are supporting the product through our expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments. And we’re already seeing a favorable impact from the expanded sales division, which we plan to build upon to increase customer frequency and reach. Meanwhile, our new manufacturing and distribution partner for Vaprisol has successfully produced the product in their facility. As we await FDA approval for making the branded product there, our partner is providing a special supply of compounded product in support of critically ill patients.
Vaprisol is the first and only intravenously administered vasopressin receptor antagonist, and it’s used to raise serum sodium level, hospitalized patients with hyponatremia, which is the most common electrolyte disorder among such patients. This completes my updates for today. And so I’ll turn it back to you, A.J.
A.J. Kazimi: Thank you, Todd. I’d now like to provide an update on our ongoing clinical activities. We continue to progress our pipeline of innovative products, which are designed to improve patient care and patient’s quality of life. Our ifetroban product candidate, which is our first new chemical entity, is being evaluated in a number of Phase II clinical trials for patients with a series of unmet medical needs. It’s now been dosed in over 1,400 subjects and has been found to be both safe and well tolerated in those individuals. We’ve initiated our newest clinical program in medical centers across the country and enrollment has now begun in patients with pulmonary fibrosis, the most common form of progressive fibrosing interstitial lung disease.
