Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting
- SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens
A standard of care in the treatment of breast cancer and other cancer
types, AC-based regimens are among the most commonly prescribed highly
emetogenic chemotherapy regimens as defined by both the National
Comprehensive Cancer Network (NCCN) and the
American Society of Clinical Oncology( ASCO)
- U.S. commercial launch of SUSTOL is planned for the fourth quarter of 2016
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SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).
“Despite advances in the management of CINV, up to half of patients
receiving chemotherapy can still experience CINV, with delayed CINV
being particularly challenging to control,” commented
The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical trials that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2-5 following chemotherapy).
"The SUSTOL clinical trial populations and results are highly
representative of cancer patients in our real-world clinical practice,”
"We would like to thank the investigators, caregivers and most of all
the patients who have helped us to achieve this important milestone,”
commented Barry D. Quart, PharmD, Chief Executive Officer of
"The approval of SUSTOL is a major step in Heron’s evolution into a
fully-integrated biopharmaceutical company with both development and
commercial capabilities," said
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About SUSTOL® (granisetron) extended-release injection
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical trials that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2-5 following chemotherapy).
Important Safety Information for SUSTOL
SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.
Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.
Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.
Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.
Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.
Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.
Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.
Please see accompanying Full Prescribing Information at www.SUSTOL.com
About Chemotherapy-Induced Nausea and Vomiting (CINV)
While chemotherapy is one of the most effective and common used
therapies to help patients fight cancer, it is accompanied by
debilitating side effects, including varying degrees of nausea and
vomiting, often attributed as a leading cause of premature
discontinuation of cancer treatment. Delayed nausea and vomiting, which
occurs 2-5 days following chemotherapy treatment, is considered
particularly debilitating for patients. The National Comprehensive
Cancer Network (NCCN) and the
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, including, but not limited to, those
associated with: the potential market opportunity for SUSTOL and
expected timing of the SUSTOL commercial launch, safety information for
SUSTOL, 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, the commercial acceptance of our products, our financial
position, business plans and our ability to raise additional capital,
and other risks and uncertainties identified in the Company's filings
Investor Relations and Media Contact:
Heron Therapeutics, Inc.
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations