Heron Therapeutics Initiates Phase 3 Label Expansion Study of SUSTOL™
03/31/2014
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Study will evaluate the prevention of delayed-onset chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy
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
“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
About SUSTOL
Heron's lead product candidate, SUSTOL™ (formerly known as APF530), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly emetogenic chemotherapy (HEC). SUSTOL contains the 5-HT3 receptor antagonist granisetron formulated in the Company's proprietary Biochronomer™ polymer-based drug delivery platform, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for SUSTOL because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About
In addition to SUSTOL, Heron is also utilizing its proprietary,
extended-release Biochronomer™ technology to develop other drugs
designed to extend the duration of action of known active ingredients to
address important unmet medical needs. In
Forward Looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the potential approval of SUSTOL (formerly
APF530) and the potential timing for such approval, if approved at all,
as well as risks and benefits relating to listing on the
Source:
Investor Relations:
For Heron Therapeutics, Inc.
Michael
Rice, 646-597-6979
mrice@lifesciadvisors.com
or
Jennifer
Capuzelo, 858-703-6063
jcapuzelo@herontx.com
or
Corporate:
Heron
Therapeutics, Inc.
Stephen R. Davis, 650-366-2626
Executive
Vice President and Chief Operating Officer