Heron has had a successful outcome in the third phase of its clinical trial for its upcoming nausea drug, SUSTOL. This means that they are ready to issue another market application to the FDA, in order for the drug to receive approval.
SUSTOL is a strong anti-nausea drug, meant to be used for patients who undergo chemotherapy. In order to test out its potency, SUSTOL was included in a three-drug combination and compared to the standard of care, that is in use at the moment.
The study was conducted on 900 patients, who were administered highly emetogenic chemotherapy medication and then were separated into two separate groups. The first group represented the whiteness group and the subjects included in it received the standard of care drug combination, that consists of ondansetron, fosaprepitant and dexamethason.
The second group was the one that SUSTOL was tested on. The patients from this group were administered SUSTOL, which is granisetron, with an extended release, associated with fosaprepitant and dexamethasone.
The results were in favor of the SUSTOL group, as 67% of the patients included in it responded to the course of medication, compared to the 57% who responded who the standard of care combination.
These results are extremely promising for the new Heron drug. It now has a chance of being included in the treatment of patients undergoing chemotherapy in the future, after it receives its FDA approval.
However, this is going to take quite some time to happen, as the application is expected to be sent to the FDA around mid-2015. Afterwards, it is not certain how much will the FDA take to verify the results of the clinical studies conducted by Heron and eventually decide if this time they will approve SUSTOL.
Heron has previously sent in applications for SUSTOL to the FDA, but they got rejected every time, because their file was in need of additional data.
This time though, it looks like SUSTOL might be ready for its long awaited approval. If the FDA will actually consider that its testing phase is complete, then the new nausea drug will become one of the most effective in this group of medication.
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