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Post by lakers on Oct 1, 2016 1:08:10 GMT -5
Ray said, "Palonosertron is in the early technical assessment phase with preclinical work expected to begin in the third quarter of 2016 followed by clinical trials beginning in second quarter of 2017. Again we are looking for a development partner for this program. Ideally, company or companies already in the oncology supportive care space.
There are many advantages to the oral inhalation while it avoids the need for IV access or having access to the patient's port, it can be used when oral agents are not practical, for example, with mucositis. It can be self-administered, for example, to prevent anticipatory nausea and vomiting. It has the potential to decrease the cost of care, nursing time, pharmacy cost, et cetera. And it can be used in multiday regimens."
There is a major adverse effect that chemotherapy has on many patients' mucous membrane that extends from their mouth to their anus.
The competition is Aloxi, a palonosertron drug for treating nausea and vomiting, is already approved by the FDA. Eisai, a large Japanese drug company has this drug in their portfolio. Eisai has the drug in both pill form and for IV delivery.
On October 13th, 2015, the FDA approved two generic versions of Aloxi for IV dosing regimens.
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