Heron Therapeutics Provides Update on FDA Review of SUSTOL® NDA
April 18 2016 - 4:01PM
Business Wire
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.
Forward-Looking Statements
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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version on businesswire.com: http://www.businesswire.com/news/home/20160418006598/en/
Heron Therapeutics, Inc.Investor Relations
Contact:Jennifer Capuzelo, 858-703-6063Associate Director,
Investor Relationsjcapuzelo@herontx.comorCorporate
Contact:Barry D. Quart, 650-366-2626Pharm D., Chief Executive
Officer
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