Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI®, SUSTOL®, and APONVIE® as Alternatives During the Potential Shortage of Intravenous Fluids
SAN DIEGO, Oct. 10, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today reaffirmed the Company's ability to supply CINVANTI® (aprepitant) injectable emulsion and SUSTOL® (granisetron) extended-release injection for Chemotherapy Induced Nausea and Vomiting ("CINV") prevention and APONVIE® for Postoperative Nausea and Vomiting ("PONV") prevention given the temporary shortage of intravenous ("IV") fluids which is expected as the result of Hurricane Helene. As alternatives to products that require dilution with IV fluids, CINVANTI, SUSTOL, and APONVIE are supplied in ready-to-administer formulations that do not require additional dilution with IV fluids in what may be a time of critical shortage.
As widely reported, the potential disruption in the supply of intravenously administered fluids is a result of the temporary closure of a major suppliers' manufacturing site in Marion, North Carolina which was impacted by Hurricane Helene. The Marion facility is believed to supply up to 60% of the IV fluid market in the U.S.
"In the wake of Hurricane Helene, and with the recently announced potential supply disruption for IV fluids, Heron has received outreach from several health systems preparing to maintain continuity of care," said Craig Collard, Chief Executive Officer of Heron. "Our team is committed to ensuring timely delivery of our products throughout the U.S. during the potential shortage of IV fluids as we understand the importance of preventing CINV and PONV for both patients and providers."
CINVANTI, SUSTOL, and APONVIE are available through major wholesalers and specialty distributors, and further information can be obtained by calling the Company's information line at 844-HERON11 (844-437-6611).
About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is indicated in adults 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. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV 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-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® 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 studies 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 (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
About APONVIE for Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. 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 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. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for APONVIE®, CINVANTI® and SUSTOL®. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Investor Relations and Media Contact:
Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com 858-251-4400
