Our mission is to improve the lives of patients by developing novel, best-in-class treatments to address some of the most important unmet patient needs. We aim to develop patient-focused solutions by applying our innovative science and technologies with well-known pharmacology.
Our product portfolio includes the following:
- SUSTOL® (granisetron) extended-release injection is a serotonin-3 (5-HT3) receptor antagonist that is approved by the U.S. Food and Drug Administration (FDA) and 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. See Indication and Important Safety Information Below.
- CINVANTI® (aprepitant) injectable emulsion, for intravenous use is a substance P/neurokinin-1 (NK1) receptor antagonist that is approved by the FDA and is indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen; and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. In February 2019, the FDA approved the administration of CINVANTI as a 2-minute IV injection (push), providing an alternative to 30-minute IV infusion. CINVANTI is now the only IV NK1 RA that offers the operational flexibility of a 2-minute IV push. In October 2019, the FDA approved CINVANTI to be administered as a 130-mg, single-dose regimen on Day 1 for MEC as well as HEC. This eliminates the need for patients to take oral aprepitant on Days 2 or 3. The CINVANTI label also includes the 3-day dose MEC regimen that requires oral aprepitant on Days 2 and 3. Limitations of Use: CINVANTI has not been studied for treatment of established nausea and vomiting. See Indication and Important Safety Information Below. In July 2020, we initiated a Phase 2 clinical study evaluating CINVANTI in early hospitalized patients with Coronavirus Disease 2019 (COVID-19).
- HTX-011 (ZYNRELEF™)* (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA. HTX-011 is in development to reduce postoperative pain for 72 hours and reduce the need for opioid analgesics. It is an extended-release, dual-acting local anesthetic™ (DALA™) applied into the surgical site. It utilizes a mechanism of action that combines bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. HTX-011 is the first and only non-opioid under review for postoperative pain management to receive all 3 FDA designations intended to expedite review of new drugs. The FDA designations include Fast Track meaning it has the potential to address life-threatening conditions and unmet medical needs, Breakthrough Therapy as it could be a substantial improvement over existing therapies, and Priority Review as it may be a significant advancement in treatment. Heron has conducted the Phase 3 clinical trials EPOCH 1 (bunionectomy) and EPOCH 2 (herniorrhaphy), a Phase 2b trial in total knee arthroplasty, and follow-on studies in each of these models in which HTX-011 patients were treated with an additional scheduled postoperative regimen of oral non-opioid analgesics. Heron is conducting The HOPE (Helping Opioid Prescription Elimination) Project evaluating HTX-011 as the foundation of non-opioid multimodal analgesia (MMA). Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018. A complete response letter (CRL) was received from the FDA regarding the NDA for HTX-011 in June 2020, relating to non‑clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls (CMC) issues were identified. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a Prescription Drug User Fee Act goal date of May 12, 2021. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC’s centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area, including the United Kingdom.
*ZYNRELEF is the approved trade name for HTX-011 in the European Union.
SUSTOL, CINVANTI, and our investigational product candidates utilize our innovative formulation science and technology platforms, including our proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a longer period of time with a single injection or application.
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.
Important Safety Information
SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.
Warnings and Precautions
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.
Use in Specific Populations
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 full Prescribing Information including Medication Guide or visit www.SUSTOL.com.
CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen; and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.
Limitations of Use: CINVANTI has not been studied for treatment of established nausea and vomiting.
Important Safety Information
CINVANTI is contraindicated in patients with hypersensitivity to any of the components of CINVANTI.
Concurrent use of pimozide with CINVANTI is contraindicated.
Warnings and Precautions
Clinically Significant CYP3A4 Drug Interactions
Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4.
- Use of CINVANTI with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug.
- Use of pimozide with CINVANTI is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide.
- Use of CINVANTI with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to CINVANTI.
- Use of CINVANTI with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of CINVANTI.
Serious hypersensitivity reactions, including anaphylaxis, during or soon after administration of CINVANTI have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. If hypersensitivity reactions occur, discontinue CINVANTI. Do not reinitiate CINVANTI in patients who experience these symptoms with previous use.
Decrease in INR with Concomitant Warfarin
Co-administration of CINVANTI with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of CINVANTI with each chemotherapy cycle.
Risk of Reduced Efficacy of Hormonal Contraceptives
The efficacy of hormonal contraceptives may be reduced during administration of and for 28 days following the last dose of CINVANTI. Advise patients to use effective alternative or back-up methods of non-hormonal contraception during treatment with CINVANTI and for 1 month following administration of CINVANTI or oral aprepitant, whichever is administered last.
Use in Specific Populations
Avoid use of CINVANTI in pregnant women as alcohol is an inactive ingredient for CINVANTI. There is no safe level of alcohol exposure in pregnancy.
The most common adverse reactions are:
- Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity.
- 3-day oral aprepitant with MEC (≥1% and greater than standard therapy): fatigue and eructation.
- Single-dose fosaprepitant with HEC: generally similar to 3-day oral aprepitant. In addition, infusion site reactions (3%) occurred.
- Single-dose CINVANTI (≥2%): headache and fatigue. The safety profile of CINVANTI in healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.
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