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news.BioDelivery Sciences International has announced that it has received written notification from the FDA that its new drug application for Emezine, an orally administered anti nausea and vomiting drug, has been accepted for review.
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BDSI filed the new drug application (NDA) in late April 2005, and this written notification indicates that the FDA review of the product is now underway. The FDA has up to 10 months from the date of NDA submission to review and render a decision on the application as to whether it is approvable or not.
Emezine is a formulation of prochlorperazine, a currently approved agent for the treatment of nausea and vomiting. Emezine is conveniently administered by placing the dissolving tablet between the upper lip and gum, thereby delivering the drug across the membrane of the mouth.
It is hoped that that Emezine will give physicians a patient-friendly alternative to injections or suppositories for the treatment of nausea and vomiting associated with a wide range of conditions such as surgery, chemotherapy and migraine attacks.
Dr Mark Sirgo, BDSI’s President and COO, said: “We are very gratified that the review process for Emezine is underway and we look forward to working with the FDA on this project.”