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Advanced Biochronomer™ combination product
formulation HTX-011 demonstrates significantly reduced pain compared
to Exparel® for up to 72 hours post-surgery
REDWOOD CITY, Calif.--(BUSINESS WIRE)--May 14, 2014--
Heron Therapeutics, Inc. (NASDAQ: HRTX), a specialty pharmaceutical
company, today announced that it has selected HTX-011, a unique
combination product utilizing its proprietary Biochronomer™
polymer-based drug delivery platform, as the lead product candidate for
its post-surgical pain program. HTX-011 is designed to slowly release
the local analgesic agent bupivacaine and the NSAID meloxicam locally at
the site of the surgery over 3-5 days. By slowly delivering these agents
directly to the location of the pain, lower doses can be used, which
should result in greater efficacy with a lower risk of side effects.
In a validated animal model, HTX-011 significantly reduced mean pain
intensity compared to the current market leader, Exparel® for
up to 72 hours following surgery. Based on these results, the company
has initiated a Phase 1 enabling toxicology study, to be followed by the
initiation of a Phase 1 study in the fall.
“There is still a significant need to improve pain relief and reduce the
use of opiate analgesics post-surgery. We are excited that our program
has the potential to address these issues better than currently
available treatments,” commented Barry D. Quart, Pharm.D., Chief
Executive Officer of Heron Therapeutics. “Having selected a lead product
candidate for this program, which includes two well-known approved
drugs, and which has demonstrated significant efficacy in an animal
model of post-surgical pain, we look forward to initiating a Phase 1
clinical trial this fall, quickly to be followed by Phase 2 studies.”
About Heron’s Post-Surgical Pain Program
Heron is utilizing its proprietary Biochronomer™ polymer-based drug
delivery platform to develop drugs designed to extend the duration of
action of known active ingredients to address important unmet medical
needs. In November 2013, the Company announced movement into full
development of an established local anesthetic for the treatment of
post-surgical pain formulated with its Biochronomer extended release
technology. In recently completed, animal models of post-surgical pain,
the Company's drug candidates demonstrated statistically significant
pain relief for five days, representing the potential to significantly
reduce the need for opiates post-surgery and the length of post-surgical
hospital stays. Heron’s lead product candidate in this program, HTX-011,
is a unique combination of local analgesic agent bupivacaine and the
NSAID meloxicam utilizing its Biochronomer extended release technology.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) is a specialty
pharmaceutical company developing products using its proprietary
Biochronomer™ polymer-based drug delivery platform. This drug
delivery platform is designed to improve the therapeutic profile of
injectable pharmaceuticals by converting them from products that must be
injected once or twice per day to products that need to be injected only
once every one or two weeks. The Company’s lead product candidate, SUSTOL™
(granisetron), is being developed for the prevention of both acute- and
delayed-onset chemotherapy-induced nausea and vomiting.
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™
and the potential timing for such approval, if approved at all; risks
relating to progress in research and development of HTX-011, including
the timing of planned toxicology and clinical studies; risks related to
other programs; risks related to the launch and acceptance of new
products and other risks and uncertainties identified in the Company's
filings with the Securities and Exchange Commission. We caution
investors that forward-looking statements reflect our analysis only on
their stated date. We do not intend to update them except as required by
law.
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
jcapuzelo@herontx.com
or
Corporate
Contact:
Stephen R. Davis, 650-366-2626
Executive Vice
President and Chief Operating Officer
