Heron Therapeutics announced that it has achieved a rapid start-up of its ongoing Phase 3 clinical trial of SUSTOL for the prevention of delayed-onset chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. As a consequence of the rapid start-up, results of the delayed-HEC study are anticipated earlier than previously projected and the company now plans to include these results in its resubmission of the new drug application for SUSTOL to the U.S. Food and Drug Administration. To accommodate the inclusion of the delayed-HEC study, Heron plans to resubmit the NDA in the fourth quarter of 2014 versus the company’s previous projection of a mid-year 2014 resubmission. Subject to approval by FDA, if the study is successful, it should enable the inclusion of a delayed-HEC indication in the SUSTOL label at the time of launch of SUSTOL rather than approximately a year following launch, as previously expected.
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