FDA Approves Extended-Release Granisetron Injection for the Prevention of CINV

The first extended-release 5-HT3 receptor antagonist approved for the prevention of CINV associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens

Heron Therapeutics, Inc. announced on 10 August 2016 that the US Food and Drug Administration (FDA) has approved extended-release granisetron injection (SUSTOL®), a serotonin-3 (5-HT3) receptor antagonist 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 or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilises 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).

The SUSTOL global phase III development programme 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).

It is the first approval of a product utilising Heron’s Biochronomer polymer-based drug delivery technology. US commercial launch of SUSTOL is planned for the fourth quarter of 2016.

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. Monitoring for ISRs following SUSTOL injection is recommended and informing patients that some ISRs may occur 2 weeks or more after administration. In patients receiving antiplatelet agents or anticoagulants, the increased risk of bruising or severe haematoma should be considered prior to the use of SUSTOL.

Monitoring for constipation and decreased bowel activity and optimising patients’ current bowel regimens used for managing preexisting constipation should be considered. Patients should be instructed 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, administration of appropriate treatment and monitoring until signs and symptoms resolve are needed.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

SUSTOL should be avoided in patients with severe renal impairment. In patients with moderate renal impairment, SUSTOL should not be administered more frequently than once every 14 days.

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhoea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.
Heron wrote that their news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautioned readers that forward-looking statements are based on management’s expectations and assumptions as of the date of the 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 company other programmes, including the timing of preclinical, clinical, and manufacturing activities, safety and efficacy results from the studies, the commercial acceptance of products, financial position, business plans and ability to raise additional capital, and other risks and uncertainties identified in the company's filings with the Securities and Exchange Commission.