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news.The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics' new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV).
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Labeling negotiations are now underway. The FDA extended the original action date of 17 January twice to enable for complete review.
Sustol’s long-acting formulation is based on Heron’s Biochronomer drug delivery technology. It has been demonstrated to maintain therapeutic drug levels of granisetron for about five days with a single subcutaneous injection.
The company said it selected granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, due to its broad use by physicians depending on a record of safety and efficacy.
Sustol is being developed to prevent both acute and delayed CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).
While other 5-HT3 antagonists are approved to prevent CINV, Sustol is the first agent in the class to show a reduction in the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized phase 3 study.
Heron Therapeutics is developing novel, patient-focused solutions that apply its science and technologies to already-approved pharmacological agents.