On July 29. 2015 Galena Biopharma reported the product launch for Zuplenz(R) (ondansetron) Oral Soluble Film in the United States (Press release, MonoSol Rx, JUL 29, 2015, View Source [SID:1234508917]).
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Zuplenz is now available nationwide and is supplied in both 4 mg and 8 mg strengths. Zuplenz is clinically bioequivalent to ondansetron orally disintegrating tablets (ODT) with a safety profile equivalent to ondansetron. The novel, PharmFilm(R) oral soluble film technology utilized by Zuplenz provides for convenient delivery and several key patient benefits including:
Rapidly dissolves in the mouth in about 10 seconds
Eliminates the burden of swallowing pills during emesis and in cases of oral irritation
Does not require water to administer
Pleasant peppermint flavor with no gritty aftertaste
Non-sedating
"Ondansetron is the gold-standard treatment option for patients suffering from nausea and vomiting due to chemotherapy, radiation treatments, and surgical procedures; and, we believe the unique and innovative product attributes of Zuplenz will be a valuable treatment option for patients and physicians to relieve these debilitating side-effects," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "With the launch of Zuplenz, we will leverage our existing commercial infrastructure including our outsourced Galena Patient Services (GPS) program to work directly with the patient, prescriber, insurance provider, and pharmacy to help guide the process of getting the patient their medication once prescribed by the physician."
Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved for moderately emetogenic CINV in pediatric patients four years and older.
The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. The National Comprehensive Cancer Network (NCCN) 2014 guidelines recommend the use of ondansetron in patients with highly and moderately emetogenic cancer chemotherapy-induced and radiotherapy-induced nausea and vomiting. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. According to data from both IMS and Wolters Kluwer, the branded 5-HT3 market exceeded $1 billion in the U.S. in 2014. The product was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm(R), and manufacturer of the product.