Heron Therapeutics Provides Update on FDA Review of SUSTOL® NDA
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Apr. 18, 2016--
Heron Therapeutics, Inc. (NASDAQ: HRTX), announced today that the U.S.
Food and Drug Administration (FDA) has provided the Company with an
update on its review of the New Drug Application (NDA) for SUSTOL®
(granisetron) Injection, extended release. The FDA has indicated that
there are no substantive deficiencies in the NDA and has begun labeling
discussions with the Company.
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 medicine 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 any anticipated
time period, whether the FDA approves the SUSTOL NDA as submitted or
supports as broad of a labeled indication for SUSTOL as requested, 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.
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Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Associate Director, Investor Relations
Barry D. Quart, 650-366-2626
Pharm D., Chief