Additionally, we believe Caldolor will be eligible for special Medicare reimbursement under the new Non-Opioids Prevent Addiction in the Nation, or No Pain, legislation, which was enacted as part of the Consolidated Appropriations Act of 2023. The No Pain Act requires Medicare to provide separate and more favorable reimbursement for non-opioid products that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers. This legislation applies to products that are indicated to provide analgesia without acting upon the body’s opioid receptors. As a result, we believe that the No Pain Act will affect Medicare reimbursement for Caldolor. In the Medicare Hospital Outpatient Prospective Payment System proposed rule, the CMS requested that manufacturers with potentially applicable non-opioid products submit comments in supporting clinical evidence regarding products that should 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 are now awaiting further information from CMS expected this year, including the potential new reimbursement level for Caldolor. The Act itself is scheduled to go in effect in early 2025 and will initially apply to those products that are furnished between January 1st, 2025 and January 1st, 2028. Shifting now to Sancuso, the first and only FDA approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy. After acquiring U.S. rights to the brand in 2022, we successfully completed the transition from Kyowa Kirin to Cumberland in 2023, which included the NDA transfer.
We also successfully transferred manufacturing of the product to a new facility. Following FDA approval of that site, we have now received new supplies of Cumberland packaged product, which we will begin shipping this year. I’d like to note that 2023 Sancuso net sales were significantly lower than those we experienced in the prior year due to an inordinate amount of sales deductions. We are working to address and improve those deductions, which include fees, rebates, and product returns. During the year, we expanded our oncology sales division as we work to deliver the brand to help cancer patients tolerate their chemotherapy treatments. We are already seeing a favorable impact from this expanded sales division, which we plan to build upon to increase customer frequency and reach in 2024.
Demand for our Vaprisol product increased during the pandemic, and we work to support the expanded use of the product in hospitals and clinics during that healthcare crisis. We then shipped all remaining inventory of the product and notified the FDA that supplies of the product were not currently available. We have since transferred the product’s manufacturing to a new facility, and our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner. Meanwhile, we’ve been working with them to support a special interim supply of compounded product for critically ill patients, which we will introduce to the market — which we introduced to the market in late 2023 and we’ll begin selling in early 2024.
The companies will share in the sales of this interim compounded product, and then we will expect to file for the approval to manufacture branded Vaprisol once all FDA issues at the new site are resolved. As for RediTrex, a line of pre-filled syringes, recall that we amended our agreement with Nordic Pharma, who previously provided us with the license for the U.S. rights for the product line. As of July 1, 2023, Nordic has assumed responsibility for the product in the United States. We support our portfolio of FDA-approved medicines through three national sales divisions, including our newest, Cumberland Oncology, which is comprised of both field-based and inside sales personnel. Our hospital division calls on key institutional accounts across the country, and our field sales division covers select office-based physicians.
Lastly, I’d like to highlight Cumberland’s ongoing focus and our commitment to sustainability. We have updated our metrics, and today I’m pleased to announce the key findings for 2023, which include providing 3 million doses of our products to patients, safely disposing of nearly 6,000 pounds of damaged and expired product, and having no products recalled and no clinical trials terminated due to failure to practice good clinical standards. That completes my update for today, and so now I’ll turn it back over to you, A.J.
A. J. Kazimi: Thank you, Todd. Now I’d like to take a few minutes to provide an update on our clinical program. We continue to progress our pipeline of innovative products designed to improve patient care and patients’ quality of life. Our ifetroban product candidate, a potent and selective thromboxane receptor antagonist, is being evaluated in three phase, two clinical studies for patients with a series of unmet medical needs. It’s now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in those individuals. Patient enrollment is well underway in two of those company-sponsored Phase II clinical programs. The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis, the skin, and internal organs.
The other is evaluating ifetroban in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy or DMD. It’s a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal heart and lung muscles. We’re sponsoring the FIGTH DMD trial, a multi-center randomized placebo-controlled Phase II study, which is enrolling patients across 10 centers across the United States and centers that specialize in DMD. We’ve completed enrollment in the younger age group of patients and are now working to finish enrollment in the older patient cohort with DMD. Recall the FDA has provided grant awards of over a million dollars to support the study. We’re also developing an oral capsule of ifetroban to treat idiopathic pulmonary fibrosis or IPF, the most common form of progressive fibrosing interstitial lung disease.
Following FDA clearance of our investigational new drug application in May of 2023, we’re now in the process of initiating our Phase II FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. Recent studies have shown, ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models. Well, in addition to these sponsored studies, there are several other preclinical and pilot patient studies of ifetroban underway, including several investigator initiated studies. We believe ifetroban has the potential to benefit many patients and we look forward to sharing the results from our company sponsored studies as they emerge. Our plan is to then decide on the best development path for the product, which represents our first new chemical entity.
So with that update on our ongoing clinical trials, I’d now like to turn it over to our Chief Financial Officer, John Hamm, to review our 2023 financial results. John?
