So with that overview, now I’d like to turn to Todd Anthony. Cumberland’s Vice President, Organizational Development to further discuss our brands. Todd?
Todd Anthony: Thank you, A.J. Regarding our Vibativ product in October, we announced a new publication in the Journal antimicrobial agents and chemotherapy, detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ injection in children two to 17 years of age. The results of this study suggest that a single dose of Vibativ can be safely administered to children to fight certain serious skin and lung infections in those patients. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia as well as complicated skin and skin structure infections caused by certain gram-positive bacteria. Antimicrobial resistance poses a significant challenge in the treatment of bacterial infections necessitating the development of new antibiotic therapies.
We are pleased to see that Vibativ sales continue to improve and are up 13% year-to-date as we have a number of new initiatives underway to improve the brand’s performance. Turning next to Kristalose. Our prescription strength laxative packaged in a convenient premeasured powder dose that dissolves quickly in just four ounces of water for a clear, taste free and grid-free solution. It continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners with this year’s sales up 8% over the prior year period. Additionally, we found that the brand performs best in 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 our share of voice in that state.
We believe that this new coverage is contributing to the growth of the product. As A.J. mentioned, we believe Caldolor, our non-opioid analgesic injection product 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 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. The act is scheduled to go into effect in early 2025 and will apply to those products that are furnished between January 1, 2025, and January 1, 2028. Also, with the newly approved labeling A.J. noted, Caldolor is now the only non-opioid product approved to treat pain in infants that’s delivered through injection.
Other products in this class such as Ketorolac and meloxicam are not approved for use in children as the safety and efficacy of those drugs have not been established for pediatric patients. Acetaminophen injection is not approved for treating pain in children less than two years of age as the safety and efficacy of that drug has not been established for treating pain in those newborn infants. We are thrilled to further expand the product’s labeling for use in patients of nearly all ages and believe the product is beginning to benefit with sales up 8% so far this year. Moving now to Sancuso, which is the only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment.
We assumed commercial responsibility for the product in the United States, including its marketing, promotion, distribution, manufacturing and medical support activities early last year. And as of September 2023 have fully completed the transition of Sancuso to Cumberland. As we previously reported, the FDA approved moving the products manufacturer to a new facility and the production of supplies for Cumberland at this plant is now underway. Sancuso sales are significantly lower than those we experienced last year due to an inordinate amount of sales deductions. We are working to improve that performance and are also now supporting the brand through our expanded oncology sales division, which is comprised of both field-based and inside sales personnel.
As we reported previously, the packager for our Omeclamox-Pak brand suspended their operations due to supply issues. That facility is now under new ownership and new management, and we’re currently awaiting availability of a potential supply from their operations. We are also exploring other alternatives to restart the product’s packaging. 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. As A.J. mentioned, we have since transferred the products manufacturing to a new facility. Our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner.
