Heron Therapeutics' NDA resubmission for SUSTO Injection extended release accepted by the US FDA for review for prevention of acute and delayed chemotherapy-induced nausea and vomiting.
M2 PHARMA-September 21, 2015-Heron Therapeutics' NDA resubmission for SUSTO Injection extended release accepted by the US FDA for review for prevention of acute and delayed chemotherapy-induced nausea and vomiting
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Biotechnology company Heron Therapeutics (NasdaqCM:HRTX) announced on Friday that its New Drug Application (NDA) resubmission for SUSTOL (granisetron) Injection, extended release has been accepted for review.
The company said the US Food and Drug Administration (FDA) has accepted SUSTOL (granisetron) for review for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens.
In conjunction, the company said the US FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 17 January 2016.
This NDA filing includes data from the company's MAGIC study, its recently completed, multi-center, placebo-controlled, Phase 3 study of SUSTOL for the prevention of delayed CINV in more than 900 patients receiving HEC regimens. Data from an earlier Phase 3 study of more than 1,300 patients, which were previously submitted to the FDA, demonstrated SUSTOL's efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.
According to the company, SUSTOL (granisetron) Injection extended release, which utilises its proprietary Biochronomer drug delivery technology, is a novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV).
Granisetron, an US FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy.It has maintained therapeutic drug levels of granisetron for five days with a single subcutaneous injection, concluded the company.
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|Date:||Sep 21, 2015|
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