Breaking News From Pharma & Bio Ingredients
Clinical Trial Set for Oral Spray to Reduce Chemotherapy-Induced Nausea
Posted on 2005-02-09 15:46:00
Hana Biosciences, Inc., a biopharmaceutical company headquartered in South San Francisco, 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, the world's best-selling anti-emetic agent, currently marketed in the US by GlaxoSmithKline. Annual U.S. sales for Zofran were approximately $1.0 billion in 2003, and the product patent expires in June 2006.
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.
Subscribe via RSS
