Heron Therapeutics resubmits NDA to US FDA for SUSTOL for the prevention of chemotherapy induced nausea and vomiting.
M2 EQUITYBITES-July 21, 2015-Heron Therapeutics resubmits NDA to US FDA for SUSTOL for the prevention of chemotherapy induced nausea and vomiting
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Biotechnology company Heron Therapeutics (NasdaqCM:HRTX) said on Monday that it has resubmitted its New Drug Application (NDA) for SUSTOL 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, to the US Food and Drug Administration (FDA).
Following the re submission of SUSTOL (granisetron) Injection extended release, the company expects expects confirmation of acceptance from the US FDA, a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks as well as a six-month review by the US FDA.
The company said the NDA filing includes data from the MAGIC study, a multi-centre, placebo-controlled, Phase 3 study in patients receiving HEC agents, that evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. The study's primary endpoint was achieved.
According to the company, SUSTOL (granisetron) Injection, extended release, which utilises its proprietary Biochronomer drug delivery technology, is its 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 based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection, concluded the company.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jul 21, 2015|
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