- FDA Clears IND for HTX-011
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jun. 16, 2015--
Heron Therapeutics, Inc. (NASDAQ: HRTX) announced today that it has
initiated a Phase 2 clinical trial of HTX-011, the Company’s lead
product candidate for the prevention of post-operative pain, following
clearance from the U.S. Food and Drug Administration (FDA) of its
Investigational New Drug (IND) application for HTX-011. HTX-011, which
utilizes Heron’s proprietary Biochronomer® drug delivery
technology, is a long-acting formulation of the local anesthetic
bupivacaine in a fixed-dose combination with the anti-inflammatory
meloxicam.
The placebo-controlled, dose-finding, Phase 2 clinical trial in
approximately 60 patients undergoing bunionectomy will evaluate the
efficacy and safety of HTX-011, containing 200 mg or 400 mg of
bupivacaine combined with meloxicam, compared to placebo. In a
previously completed, placebo-controlled, Phase 1 clinical trial of
HTX-011 in healthy volunteers, the desired pharmacokinetic profile for
both bupivacaine and meloxicam was achieved, with therapeutically
relevant drug levels of bupivacaine sustained for 2-3 days. Heron
anticipates reporting top-line results from this Phase 2 clinical trial
in the second half of 2015.
“We are excited to be moving HTX-011, an innovative product candidate
targeting the large and growing post-operative pain management market,
into a Phase 2 study in an important surgical indication,” commented
Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We believe
that HTX-011 has the potential to meet our core goal of developing
best-in-class medicines with the potential to significantly improve the
lives of patients.”
About HTX-011 for Post-Operative Pain
HTX-011, which utilizes Heron’s proprietary Biochronomer®
drug delivery technology, is a long-acting formulation of the local
anesthetic bupivacaine in a fixed-dose combination with the
anti-inflammatory meloxicam for the prevention of post-operative pain.
The effective management of pain with a reduction in the use of opioids
remains an important area of unmet medical need, and HTX-011 could
potentially provide a differentiated therapeutic profile with advantages
compared to currently available pain management options. In a Phase 1
clinical trial, HTX-011 achieved the desired pharmacokinetic profile for
both bupivacaine and meloxicam. Therapeutically relevant plasma
bupivacaine levels were sustained for 2-3 days in the absence of the
large initial peak that can be observed with commercially available
formulations. The anesthetic effects of HTX-011 persisted through 96
hours, which closely correlated with plasma bupivacaine concentrations,
and HTX-011 was well-tolerated with no serious adverse events. Heron is
currently conducting a placebo-controlled, dose-finding, Phase 2
clinical trial of HTX-011 in patients undergoing bunionectomy.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a biotechnology company focused on
developing and commercializing best-in-class pharmaceutical products
that address major unmet medical needs. The Company has four product
candidates in development for patients suffering from cancer and pain
and has retained commercial rights to each of these in all major
markets. SUSTOL® is an injectable, extended-release
formulation of granisetron that is being developed for the prevention of
both acute and delayed chemotherapy-induced nausea and vomiting (CINV)
following the administration of moderately emetogenic chemotherapy (MEC)
or highly emetogenic chemotherapy (HEC) agents. Affecting 70-80% of
patients undergoing chemotherapy, CINV is one of chemotherapy’s most
debilitating side effects and is a leading cause of premature
discontinuation of cancer treatment. Heron recently reported positive,
top-line results from its Phase 3 MAGIC study and intends to resubmit
its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug
Administration (FDA) in mid-2015. HTX-019, also being developed for the
prevention of CINV, has the potential to become the first polysorbate
80-free, intravenous formulation of aprepitant, a neurokinin-1 (NK1)
receptor antagonist. Heron intends to file an NDA for HTX-019 using the
505(b)(2) pathway in the second half of 2016. HTX-011, a long-acting
formulation of the local anesthetic bupivacaine in a fixed-dose
combination with the anti-inflammatory meloxicam, is in Phase 2 clinical
development for the prevention of post-operative pain. HTX-003, a
long-acting formulation of buprenorphine, is being developed for the
potential management of chronic pain and opioid addiction. Many of
Heron’s product candidates utilize its proprietary Biochronomer®
drug delivery technology, which can deliver therapeutic levels of a wide
range of otherwise short-acting drugs over a period of days to weeks
with a single injection.
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 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: the timing and acceptance of the Company’s resubmission
of its New Drug Application (NDA) for SUSTOL® whether the
U.S. Food and Drug Administration (FDA) approves the SUSTOL NDA as
submitted or supports as broad of a labeled indication for SUSTOL as
requested, the progress in the research and development of HTX-019,
HTX-011, HTX-003 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, the launch and 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. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150616005319/en/
Source: Heron Therapeutics, Inc.
Heron Therapeutics, Inc.
Investor Relations Contact:
Jennifer
Capuzelo, 858-703-6063
Sr. Manager, Investor Relations
jcapuzelo@herontx.com
or
Corporate
Contact:
Barry D. Quart, 650-366-2626
Pharm D., Chief
Executive Officer
