Stage (next event)
Quarterly Sales (Approved)
March 05, 2021 (Est)
Catalyst Info & Data Links
TITLE: Quarterly sales for Sustol for nausea associated (FDA-approved drug)
WHAT IS THE CATALYST EVENT?
Approved quarterly sales
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
March 05, 2021 (Est)
2015 Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. Support Care Cancer 23, 723–732 (2015).
Mechanism of Action
MECHANSIM OF ACTION/ RATIONALE
Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2; for alpha1-, alpha2-, or beta-adrenoreceptors; for dopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioid receptors.
Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.
Source: FDA Label (section 12.1)
5-hydroxytryptamine3 (5-HT3) receptor antagonist:
Aloxi ® (Palonosetron HCl) - Eisai
Zofran (ondansetron) - GSK
Kytril (granisetron) - Roche
Zuplenz (ondansetron) - Midatech Pharma
~4 million people per year receiving chemotherapy
~CINV affects 70-80% of patients undergoing chemotherapy
Updated by HC
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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