Zuplenz is indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV)
Novel, oral soluble film technology provides convenient delivery and key patient benefits
PORTLAND, Ore., July 29, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced the product launch for Zuplenz(R) (ondansetron) Oral Soluble Film in the United States.
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:
"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.
About Zuplenz(R) (ondansetron) Oral Soluble Film
Zuplenz(R) (ondansetron) Oral Soluble Film is approved by the U.S. Food and Drug Administration (FDA) 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. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation.
Zuplenz utilizes the proprietary PharmFilm(R) technology as an oral soluble film that dissolves on the tongue in about 10 seconds. This rapidly dissolving film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, potentially increasing patient adherence. Zuplenz is supplied in both 4 mg and 8 mg ondansetron strengths with clinical bioequivalence to ondansetron orally disintegrating tablets (ODT) and a safety profile equivalent to ondansetron. For more information on Zuplenz, please visit www.Zuplenz.com.
About Chemotherapy-, Radiation- and Post Operative-Induced Nausea and Vomiting
It is estimated that up to 90% of patients receiving chemotherapy experience CINV. CINV patients ranked nausea and vomiting among the most distressing and severe symptoms associated with chemotherapy, and CINV has shown a strong negative impact on social, cognitive, and physical functioning for these patients.
Up to 80% of patients undergoing radiotherapy will experience RINV, and patients experiencing RINV report lower quality of life, reduced physical capacity, more anxiety, and depressed moods. Importantly, if RINV is not effectively treated, it may cause patients to drop out of their radiotherapy treatment.
Postoperative nausea and vomiting (PONV) occurs in 80% of high-risk patients following surgery as a result of anesthesia and/or the pain medications given during their operation. PONV can have serious side effects, including dehydration, electrolyte imbalance, and increased blood pressure, and can require longer hospital stays.
About Galena Biopharma
Galena Biopharma, Inc. (GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax(TM) (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral(R)(fentanyl) Sublingual Tablets and Zuplenz(R) (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Zuplenz(R) and development of Galena's product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners, and Zuplenz is licensed by Galena Biopharma, Inc.