Heron initiates SUSTOL Phase 3 clinical trial for CINV prevention associated with emetogenic chemotherapy

Heron Therapeutics, Inc.Mar 31 2014

Heron Therapeutics, Inc. (NASDAQ: HRTX), a specialty pharmaceutical company, today announced the initiation of a Phase 3 clinical trial of SUSTOL™ (APF530), the Company's lead product candidate for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately and highly emetogenic chemotherapy. This Phase 3 clinical trial will evaluate SUSTOL for the prevention of delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC) agents and is designed to support expansion of the expected label for SUSTOL in the delayed-onset HEC setting. 

The label-expansion study is a prospective, randomized, placebo-controlled two-arm study of approximately 1000 HEC-treated patients comparing SUSTOL plus the NK-1 inhibitor fosaprepitant and dexamethasone to ondansetron plus fosaprepitant and dexamethasone. Currently, there is no long-acting 5-HT₃ receptor antagonist approved for the prevention of delayed-onset CINV after the administration of HEC agents. Published results of large clinical trials show that approximately 35 percent of patients receiving HEC agents experience CINV in the delayed phase with the currently available standard three-drug regimen, leaving a significant unmet medical need for better therapy. Based on the results of a previously completed Phase 3 trial, Heron is currently pursuing the approval of SUSTOL for the prevention of acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC) agents and the prevention of acute CINV in HEC. The Company anticipates submission of a new drug application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) mid-2014.

"We are excited to have this important label-expansion study underway, which is focused on an area of significant unmet medical need," commented Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. "Based on very strong interest from community oncologists, we anticipate rapid enrollment, with data to be available before the end of 2014. Furthermore, if successful, this study will allow us to further differentiate SUSTOL as the only 5-HT₃ receptor antagonist with demonstrated activity for the prevention of delayed-onset CINV in patients receiving the most highly emetogenic chemotherapy agents."