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Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI, SUSTOL, and APONVIE as Alternatives During the Potential Shortage of Intravenous Fluids

Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI, SUSTOL, and APONVIE as Alternatives During the Potential Shortage of Intravenous Fluids

heron therapeutics重申CINVANTI、SUSTOL和APONVIE的可用性和充足供應,作爲靜脈液短缺時的替代選項。
PR Newswire ·  10/11 04:08

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.

聖地亞哥,2024年10月10日/美通社/--商業階段的生物技術公司喜康治療公司(Nasdaq: HRTX)("喜康"或"公司")今天重申公司供應CINVANTI(依普替汀)注射乳劑和SUSTOL(格列司其林)緩釋注射液用於預防化療引起的噁心和嘔吐("CINV"),以及供應APONVIE用於術後噁心和嘔吐("PONV")預防的能力,鑑於颶風赫蓮可能導致靜脈("IV")液體短缺。作爲需要用IV液體稀釋的產品的替代品,CINVANTI、SUSTOL和APONVIE提供了準備好的給藥配方,不需要在可能是關鍵短缺時額外稀釋IV液體。

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.

如廣泛報道,靜脈給藥液體供應的潛在中斷是由於北卡羅來納州馬裏翁市一個主要供應商的製造基地暫時關閉,此地受到颶風赫蓮的影響。據信,馬裏翁工廠可能爲美國的IV液體市場供應多達60%。

"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."

喜康公司首席執行官Craig Collard表示:"在颶風赫蓮的影響下,以及最近宣佈的IV液體潛在供應中斷,喜康已接到幾家衛生系統的聯絡,準備維持連續關愛。" "我們的團隊致力於確保在美國全境及可能缺少IV液體時及時交付我們的產品,因爲我們了解預防CINV和PONV對患者和醫療提供者的重要性。"

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).

CINVANTI、SUSTOL和APONVIE通過主要批發商和專業分銷商提供,可以致電公司信息熱線844-HERON11(844-437-6611)獲取更多信息。

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

關於用於化療誘導噁心和嘔吐(CINV)預防的CINVANTI

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.

CINVANTI與其他抗噁心藥物結合使用,適用於成人,用於預防與初次及重複應用高度致嘔原性抗癌化療(HEC)包括高劑量順鉑的急性和延遲噁心和嘔吐,用於初次及重複應用中度致嘔原性抗癌化療(MEC)的延遲噁心和嘔吐作爲單劑方案,以及用於初次及重複應用MEC的噁心和嘔吐作爲連續3天方案。CINVANTI是依普替汀的IV製劑,是首個直接提供依普替汀的IV製劑,是EMEND膠囊中活性成分依普替汀的首個IV製劑。依普替汀(包括其前藥)是單一作用NK1 RA,可顯著減少噁心和嘔吐的急性階段(化療後0-24小時)和延遲階段(化療後24-120小時)中的噁心和嘔吐。FDA批准的CINVANTI美國處方信息中包括100毫克或130毫克作爲30分鐘IV輸液或2分鐘IV注射的給藥途徑。

Please see full prescribing information at .

請查看完整的處方信息請參閱 .

About SUSTOL for CINV Prevention

有關CINV預防的SUSTOL

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).

SUSTOL適用於成人,與其他止吐藥聯合使用,用於預防初次和重複中等噁心化療(MEC)或蒽環磷酰胺和環磷酰胺(AC)聯合化療方案相關的噁心和嘔吐的急性和延遲發作。 SUSTOL是一種延長釋放的可注射5-羥色胺3型拮抗劑,利用Heron的Biochronomer藥物給藥技術,以維持格拉諾塞龍的治療水平≥5天。 SUSTOL的全球3期開發計劃由兩項大型的基於指南的臨床研究組成,在這兩項研究中,對2000多名癌症患者評估了SUSTOL在預防噁心和嘔吐方面的有效性和安全性。 SUSTOL在預防噁心和嘔吐方面的有效性在急性期(化療後0-24小時)和延遲期(化療後24-120小時)均有評估。

Please see full prescribing information at .

請查看完整的處方信息請參閱 .

About APONVIE for Postoperative Nausea and Vomiting (PONV)

關於APONVIE用於術後噁心和嘔吐(PONV)的

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.

APONVIE是一種物質NK1受體拮抗劑(RA),適用於成人預防PONV。 通過30秒的靜脈推注給藥,已證明APONVIE 32毫克與口服阿司匹坦40毫克具有生物等效性,並迅速達到治療藥物水平。 APONVIE與Heron批准的藥物CINVANTI相同。 APONVIE用單劑量瓶提供,可提供用於PONV的完整32毫克劑量。 APONVIE於2022年9月獲得FDA批准,並於2023年3月6日在美國正式上市。

Please see full prescribing information at .

請查看完整的處方信息: .

About Heron Therapeutics, Inc.

關於Heron Therapeutics,Inc。

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 .

Heron Therapeutics, Inc.是一家專注於通過開發和商業化改善患者生活、提高醫療保健水平的生物技術公司。我們擁有先進的科學、專利技術和創新的藥物發現和開發方法,使我們能夠創建和商業化一系列產品,旨在提高急診和腫瘤患者的護理標準。欲了解更多信息,請訪問 .

Forward-looking Statements

前瞻性聲明

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.

本新聞稿包含根據1995年《私人證券訴訟改革法》定義的「前瞻性陳述」。Heron提醒讀者,前瞻性陳述基於管理層對本新聞發佈日期的期望和假設,並受到可能導致實際結果出現重大差異的某些風險和不確定性的影響。因此,您不應過分依賴前瞻性陳述。前瞻性陳述的示例包括,但不限於,我們就APONVIE、CINVANTI和SUSTOL潛在市場機會發表的聲明。導致實際結果與前瞻性陳述有重大差異的重要因素將在我們最近的10-K年度報告和任何後續的10-Q季度報告以及我們提交給證券交易委員會的其他報告中闡明,其中包括「風險因素」標題下的內容。前瞻性陳述僅代表其陳述日期的分析,Heron不承擔更新或修訂這些陳述的義務,除非法律要求。

Investor Relations and Media Contact:

投資者關係和媒體聯繫:

Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
[email protected]
858-251-4400

Ira Duarte
首席財務執行官
Heron Therapeutics,Inc.
[email protected]
858-251-4400

SOURCE Heron Therapeutics, Inc.

消息來源:Heron Therapeutics,Inc。

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