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.