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FDA Approves Heron Therapeutics' Post-Op Nausea Treatment

FDA Approves Heron Therapeutics' Post-Op Nausea Treatment

FDA批准Heron Treateutics的手術後噁心治療
Benzinga Real-time News ·  2022/09/19 06:42
  • The FDA approved Heron Therapeutics Inc's (NASDAQ:HRTX) Aponvie (aprepitant) injectable emulsion for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.
  • Aponvie is the first and only IV formulation of aprepitant for PONV prevention.
  • Aponvie is provided in a single-dose vial that delivers the full 32 mg dose approved for PONV. The ready-to-use, easy-to-administer, innovative IV formulation ensures rapid and consistent exposure in surgery patients.
  • Related: Heron Shares Jump After Equity Financing, Q2 Earnings.
  • Administered via a single 30-second IV injection, Aponvie reaches drug levels associated with ≥97% receptor occupancy in the brain within five minutes and maintains therapeutic plasma concentrations for at least 48 hours.
  • Clinical studies comparing oral aprepitant to the current standard of care, IV ondansetron, demonstrated that aprepitant was more effective.
  • Treatment with aprepitant resulted in approximately 50% fewer patients vomiting in the first 24 and 48 hours compared to ondansetron. In clinical studies, Aponvie was well-tolerated and presented a safety profile comparable to oral aprepitant.
  • In a 2020 Cochrane meta-analysis, aprepitant was ranked as the most effective drug approved for PONV prophylaxis, the most effective for preventing vomiting in the first 24 hours post-surgery, and the drug with the fewest adverse events.
  • Price Action: HRTX shares closed 4.11% lower at $4.67 on Friday.
  • 美國食品和藥物管理局批准蒼鷺治療公司納斯達克：HRTX)阿蓬韋(阿蓬韋)靜脈注射乳劑用於預防成人術後噁心嘔吐。
  • 阿蓬維是第一個也是唯一一個用於預防PONV的靜脈注射製劑。
  • Aponvie以單劑瓶裝提供，可提供批准用於PONV的全部32毫克劑量。易於使用、易於管理、創新的靜脈注射配方確保了手術患者快速和一致的暴露。
  • 相關： Heron股價在股權融資後大幅上漲，第二季度收益.
  • 通過一次30秒的靜脈注射，Aponvie在5分鐘內達到與大腦中≥97%受體佔有率相關的藥物水平，並在至少48小時內保持治療性血漿濃度。
  • 臨牀研究比較了口服安非他明和目前的護理標準，即靜脈注射恩丹西酮，結果表明，安非他明更有效。
  • 與恩丹西酮相比，使用approant治療後24小時和48小時內嘔吐的患者減少了約50%。在臨牀研究中，阿蓬維耐受性良好，並呈現出與口服阿蓬維相當的安全性。
  • 在2020年的Cochrane薈萃分析中，Approant被評為被批准用於PONV預防的最有效的藥物，在術後24小時內預防嘔吐最有效，不良事件最少。
  • 價格行動：HRTX股價週五收低4.11%，報4.67美元。
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