Zuplenz (ondansetron) oral soluble film prevents post operative, chemotherapy- and radiation-induced nausea and vomiting using PharmFilm® drug delivery technology
Warren, N.J., August 5, 2015 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to develop treatments that improve patient outcomes and address unmet needs, announced that its commercial partner, Galena Biopharma, has launched Zuplenz® (ondansetron) oral soluble film in the U.S. Monosol Rx, the developer of PharmFilm, is the world leader in the development of oral soluble film for prescription drugs. PharmFilm enables the administration of pharmaceutical products via a film that dissolves in the mouth.
Keith Kendall, MonoSol Rx Chief Executive Officer, said, "The launch of Zuplenz oral soluble film represents a major step forward for MonoSol Rx and PharmFilm and has the potential to be an important revenue driver for the Company. Galena Biopharma has a strong presence in oncology, and we believe that their extensive knowledge of the drug in combination with the significant advantages of an oral soluble formulation for patients with nausea related to cancer therapies made them an ideal commercial partner for Zuplenz."
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 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. We believe the unique and innovative product attributes of Zuplenz oral soluble film will be a valuable treatment option for patients and physicians to relieve the debilitating side-effects associated with chemotherapy and radiotherapy," said Mark W. Schwartz, Ph.D., Galena Biopharma President and Chief Executive Officer.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® drug delivery technology to develop products that improve patient outcomes and address unmet needs. These pharmaceutical and over-the-counter products are developed independently and with partners. PharmFilm can provide a benefit to patients by improving the efficacy, safety, and convenience of currently marketed pharmaceutical products. PharmFilm enhances new pharmaceutical products with the unique, multi-faceted value proposition afforded by film delivery. MonoSol Rx's leadership in film drug delivery is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com. More information about PharmFilm can be found at www.pharmfilm.com. Zuplenz® and PharmFilm® are registered trademarks of MonoSol Rx.
About Zuplenz® (ondansetron) Oral Soluble Film
Zuplenz® (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® 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 Galena Biopharma
Galena Biopharma, Inc. (NASDAQ: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™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) sublingual tablets and Zuplenz®(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.