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.
- 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 and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). 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. Limitations of Use: CINVANTI has not been studied for treatment of established nausea and vomiting. See Indication and Important Safety Information.
- HTX-011 (bupivacaine and meloxicam) is an investigational drug that has not been approved by the FDA or other international regulatory authority. It is a fixed-dose combination of the local anesthetic bupivacaine with the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. Inclusion of low-dose meloxicam in HTX-011 reduces local inflammation and normalizes the acidic environment caused by surgery, allowing enhanced penetration of bupivacaine into the nerves and thereby potentiating its effect. HTX-011 is in development for application into the surgical site to reduce postoperative pain for 72 hours and the need for opioid analgesics. It was granted Fast Track Designation from the FDA in the fourth quarter of 2017 and Breakthrough Therapy Designation from the FDA in the second quarter of 2018. Heron released positive Topline Phase 3 Results for HTX-011 in the EPOCH 1 study (bunionectomy) and the EPOCH 2 study (hernia repair) and positive Topline Phase 2b Results for HTX-011 in subjects undergoing total knee arthroplasty and breast augmentation. A Complete Response Letter was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing, and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. A Marketing Authorisation Application for HTX-011 was validated by the European Medicines Agency in March 2019 for review under the Centralised Procedure.
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.
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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.
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 and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
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 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 aprepitant.
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 reinstate 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 with the 3-day oral aprepitant regimen in conjunction with MEC (≥1% and greater than standard therapy) were fatigue and eructation.
The most common adverse reactions with the single-dose intravenous fosaprepitant regimen in conjunction with HEC were generally similar to that seen in prior HEC studies with oral aprepitant. In addition, infusion site reactions (3%) occurred.
The most common adverse reactions with single-dose CINVANTI (≥2%) were 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.
Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.