From rxpgnews.com
Ondansetron Lingual Spray for Chemotherapy Induced Nausea and Vomiting
By Akanksha, Pharmacology Correspondent
Feb 10, 2005, 13:04
Hana Biosciences, Inc.announced today an initial clinical study that will compare the pharmacokinetic profile of the lingual spray formulation of ondansetron to the approved oral dosage of Zofran(R), the world's best-selling anti-emetic agent, currently marketed in the US by GlaxoSmithKline.
Based on successful results of this pilot pharmacokinetic trial in healthy volunteers, Hana intends to file an Investigational New Drug (IND) Application to commence an abbreviated clinical development program designed to support a 505(b)(2) submission, a form of New Drug Application (NDA) that relies on data in previously approved NDAs and published literature. If the results are successful, Hana expects the oral spray version to be available in 2007.
Ondansetron belongs to a class of drugs known as 5HT3 antagonists that are widely used to prevent chemotherapy-induced nausea and vomiting. According to the National Cancer Institute over 500,000 Americans received chemotherapy in 2004, and the majority of these patients received an antiemetic such as ondansetron to prevent nausea and vomiting.
Hana acquired the rights to market the novel lingual spray formulation in the US and Canada from NovaDel Pharma,Inc.in 2004.The new formulation utilizes NovaDel's patented lingual spray drug delivery technology.This is designed to enhance convenience with a multidose formulation and to achieve more rapid onset of therapeutic activity though buccal absorption. For chemotherapy patients seeking quicker relief of nausea and vomiting, this is considered a desired benefit. NovaDel was awarded a patent directed to a lingual spray version of ondansetron in 2004.
"The convenience of a mouth spray to rapidly and effectively prevent chemotherapy-induced nausea and vomiting is a welcome addition to our anti- emetic choices, as oral ingestion of pills can be difficult in this setting," said Greg Berk, MD, Chief Medical Officer and Vice President, Hana Biosciences.
Once the pharmacokinetic profile is established, Hana plans to evaluate ondansetron lingual spray in several oncology settings, including adjuvant breast cancer, radiation therapy, and pediatrics. "We believe the convenience of the oral spray will provide improved quality of life for several specific groups of patients," Dr. Berk said.
"Nausea and vomiting associated with cancer chemotherapy continue to cause significant problems for many people, even though marked progress has been achieved over the past several years. Research into new approaches to further lessen these difficult side-effects is clearly needed," said Richard J. Gralla, MD, Co-Chair of the American Society of Clinical Oncology's Antiemetic Guideline Expert Panel.
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Hana Biosciences acquires,develops,and commercializes innovative products for the treatment of important unmet medical needs in cancer.The company is committed to creating value by building a world-class team,accelerating the development of lead product candidates,expanding its pipeline by being the alliance partner of choice,and nurturing a unique company culture.Additional information on Hana Biosciences can be found at the company's website.
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