Shares of Redwood City, CA-based Heron Therapeutics $HRTX shot up 20% on Wednesday morning after the biotech announced that the FDA has at long last approved its sustained-release formulation of Sustol (granisetron) to prevent nausea and vomiting for patients on chemo. The approval comes after a 6-year regulatory odyssey for Heron, which started with the first of two FDA rejections in 2010.
The injectable 5-HT3 receptor antagonist uses Heron’s polymer-based delivery tech to maintain efficacy for five or more days for patients.
“Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,” commented Ralph V. Boccia, the medical director for the Center for Cancer and Blood Disorders. “In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. SUSTOL, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days.”
$HRTX Sustol label includes claim for delayed vomit/nausea in AC regimen. Partial win. Didn't get broad delayed HEC claim sought after.
— Adam Feuerstein (@adamfeuerstein) August 10, 2016
Heron says it plans to make the treatment available in the fourth quarter. Its president Robert H. Rosen adds “the approval of SUSTOL is a major step in Heron’s evolution into a fully-integrated biopharmaceutical company with both development and commercial capabilities.”
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