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news.After a make-or-break meeting with the FDA, BioDelivery Sciences International said that it believes relatively minor additional studies should be enough to gain approval for its nausea and vomiting treatment, Emezine.
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The FDA informed the company in February 2006 that it would not approve the drug, but the recent meeting has given the company hope that a path to approval may be found for the drug. Shares in the company climbed around 5% after results the meeting were released.
A key element of the meeting was to determine what additional studies were needed by the FDA. In a promising development, the company believes that it will be allowed to proceed with a pathway forward that would allow the company to manage the FDA’s remaining questions through the conduct of two small pharmacokinetic studies and, in doing so, avoid the necessity of having to conduct a major efficacy and safety trial in patients.
“While we were and remain disappointed that the data submitted in the NDA raised several additional questions from the FDA resulting in the need for the collection of additional information, we now have a clear understanding of the type of additional data that will be required for product approval,” said Dr Mark Sirgo, BioDelivery Sciences’ president and CEO.