ChemioCare USA Inc. (“ChemioCare” or the “Company”), a platform company focused on proprietary transdermal delivery today announced that its Adult Ondansetron 5-day adhesive transdermal patch will initiate development and be adapted for use in pediatric Chemotherapy Induced Nausea and Vomiting (CINV).
It is recognized that when treated with chemotherapy, children (ages 5+) are more prone to vomiting than adults. CINV presents in two phases: Acute (day 1) and Delayed (days 2-5). Pediatric CINV does not have any approved or guideline-recommended treatments for the delayed phase of CINV in Highly Emetogenic Chemotherapy (HEC). Current guidelines recommend three IV infusions of a 5HT-3 receptor antagonist every four hours following chemotherapy; this treatment regimen provides protection in the Acute phase only.
“A pediatric CINV transdermal patch will address a significant unmet medical need and improve the quality of life and outcomes for children and teenagers that have to go through chemotherapy. With approximately nineteen thousand children and young adults ages 0-19 diagnosed each year, the indication will be classified as a pediatric orphan. The pediatric development program can be expected to employ the time, cost, and data protection benefits provided to orphan disease development programs” said Chairman and CEO, Pedro Lichtinger. He added, “From our initial payer and provider research, we expect broad endorsement for CMIO-ONDAN in Pediatrics and increased formulary adoption in the adult population.”
A pediatric transdermal patch leverages the breakthrough development by ChemioCare for their Ondansetron 5-day transdermal patch under development for adult CINV. These potential benefits include offering fast CINV protection when applied up to one hour prior to Chemotherapy as well as sustained protection for five days.
The pediatric transdermal patch will be the first and only protection for the Highly Emetogenic Chemotherapy (HEC) delayed stage, improving the quality of life and outcomes in children. The patch will also provide cost savings by substituting multiple IV applications, reduced infusion chair time, avoidance of stomach tubing, and avoidance of noncompliance and expulsion of medicine.
A biotech company focused on improving the profiles of generic medicines through its proprietary transdermal delivery technology. The platform technology uniquely combines high flux and sustained release into a matrix drug in adhesive patch. ChemioCare has 3 patches in development for cancer and cancer supportive care, its lead two programs are expected to enter phase 3 pivotal studies late 2019. Each product leverages the 505(b)2 regulatory path and is establishing improved efficacy and reduced or eliminated side effects from originator products.
To learn more, visit www.chemio.care
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