REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jan. 15, 2016--
Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S.
Food and Drug Administration (FDA) has informed the Company that it has
not yet completed its review of the New Drug Application (NDA) of SUSTOL®
(granisetron) Injection, extended release and would not be taking action
by the Prescription Drug User Fee Act (PDUFA) goal date of January 17,
2016 and anticipates taking action in late February 2016.
SUSTOL is a long-acting formulation of the FDA-approved
5-hydroxytryptamine type 3 (5-HT3) receptor antagonist
granisetron being developed for the prevention of both acute and delayed
chemotherapy-induced nausea and vomiting (CINV) associated with
moderately emetogenic chemotherapy (MEC) or highly emetogenic
chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary
Biochronomer® drug delivery technology, and has been shown to
maintain therapeutic drug levels of granisetron for at least five days
with a single subcutaneous injection.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company focused on improving
the lives of patients by developing best-in-class medicines that address
major unmet medical needs. Heron is developing novel, patient-focused
solutions that apply its innovative science and technologies to
already-approved pharmacological agents for patients suffering from
cancer or pain. Heron’s goal is to build on therapeutics with well-known
pharmacology by improving their tolerability and efficacy as well as
broadening their potential field of use. For more information, visit www.herontx.com.
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially. These risks and uncertainties include, but
are not limited to, those associated with: whether the U.S. Food and
Drug Administration (FDA) completes its review within the anticipated
time period, whether the FDA approves the SUSTOL NDA as submitted or
supports as broad of a labeled indication for SUSTOL as requested, the
potential market opportunity for SUSTOL and expected timing of the
commercial launch, the progress in the research and development of
HTX-019, HTX-011 and our other programs, including the timing of
preclinical, clinical, and manufacturing activities, safety and efficacy
results from our studies that may not justify the pursuit of further
development of our product candidates, acceptance of SUSTOL and new
products generally, our financial position and our ability to raise
additional capital to fund operations, if necessary, or to pursue
additional business opportunities, strategic business alliances we may
pursue or the potential acquisition of products or technologies, and our
ability to grow our organization to sustain the commercial launch for
SUSTOL, and other risks and uncertainties identified in the Company's
filings with the Securities and Exchange Commission. Forward-looking
statements reflect our analysis only on their stated date, and Heron
takes no obligation to update or revise these statements except as may
be required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160115005119/en/
Source: Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer Capuzelo, 858-703-6063
Director, Investor Relations
Barry D. Quart, Pharm D., 650-366-2626