Heron announced that the Food and Drug Administration (FDA) has approved Sustol (granisetron) extended-release injection for use in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Sustol is the first extended-release 5-HT3 receptor antagonist approved for this indication. It utilizes the Company’s Biochronomer polymer-based drug delivery technology to sustain therapeutic levels of granisetron for at least 5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).
The FDA approval was based on data from two large, guideline-based clinical rials that evaluated Sustol’s safety and efficacy in >2,000 patients with cancer. Sustol’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (Day 1 following chemotherapy) and the delayed phase (Days 2–5 following chemotherapy).
Sustol is a serotonin-3 (5-HT3) receptor antagonist that works by blocking serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. It has little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2, or for alpha1-, alph2-, or beta-adrenoreceptors.
Sustol will be available as a 10mg/0.4mL strength injection in cartons of 6 kits. Each kit contains a single-dose prefilled syringe with supplies. Sustol is anticipated to launch in the 4th quarter of 2016.
For more information call (844) 437-6611 or visit Sustol.com.