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Ensysce Biosciences Announces Successful Meeting With FDA for PF614-MPAR, a Next Generation Opioid With Overdose Protection

Ensysce Biosciences Announces Successful Meeting With FDA for PF614-MPAR, a Next Generation Opioid With Overdose Protection

Ensysce Biosciences宣佈成功與美國食品藥品管理局就具有過量保護的下一代阿片類藥物 PF614-MPAR 舉行會議
Ensysce Biosciences ·  02/21 08:00

SAN DIEGO, CA / ACCESSWIRE / February 21, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, is providing an update following its recent meeting with the Food and Drug Administration (FDA) regarding its second product, a 'Next Generation' opioid analgesic with overdose protection, PF614-MPAR.

加利福尼亞州聖地亞哥 /ACCESSWIRE/2024 年 2 月 21 日/ Ensysce Biosciences, Inc. 納斯達克股票代碼:ENSC)(“Ensysce” 或 “公司”)是一家應用變革性化學來提高處方藥安全的臨床階段公司,在最近與美國食品藥品監督管理局(FDA)就其第二款產品即具有過量保護的 “下一代” 阿片類鎮痛藥 PF614-MPAR 舉行會議後,提供了最新情況。

The meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain. The FDA provided helpful feedback and advice on non-clinical studies that are required for eventual new drug application (NDA) submission and approval. The guidance will aid in streamlining the development plans for this innovative drug candidate to bring PF614-MPAR to the market as quickly as possible.

會議重點討論了公司爲治療劇烈疼痛而設計的組合產品的非臨床計劃。FDA就最終提交和批准新藥申請(NDA)所需的非臨床研究提供了有用的反饋和建議。該指南將有助於簡化這種創新候選藥物的開發計劃,以儘快將 PF614-MPAR 推向市場。

As recently announced, PF614-MPAR was granted Breakthrough Therapy designation by the FDA which allows more frequent meetings and access to FDA experts. PF614-MPAR is a combination product of PF614, a trypsin-activated abuse protection (TAAP) oxycodone prodrug, and a trypsin inhibitor, nafamostat. PF614, Ensysce's lead drug candidate and the base for PF614-MPAR, has entered Phase 3 clinical development following its demonstration of efficacy and safety in recent trials and a recent End of Phase 2 meeting with the FDA.

正如最近宣佈的那樣,PF614-MPAR 被美國食品藥品管理局授予突破性療法稱號,這允許更頻繁地開會和接觸美國食品藥品管理局的專家。PF614-MPAR 是胰蛋白酶活化濫用保護 (TAAP) 羥考酮前藥 PF614 和胰蛋白酶抑制劑 nafamostat 的組合產物。PF614 是 Ensysce 的主要候選藥物,也是 PF614-MPAR 的基礎,在最近的試驗中以及最近與美國食品藥品管理局舉行的第二階段結束會議證明了其有效性和安全性之後,已進入三期臨床開發。

The clinical data demonstrated that PF614 delivers oxycodone with the benefit of a longer half-life than products currently on the market, providing what Ensysce believes will be more sustained pain relief with reduced adverse effects that occur following repeat dosing of shorter-acting opioid analgesics. PF614-MPAR takes the product to the next level with overdose protection, by the addition of nafamostat which "switches off" the release of oxycodone when too many doses are ingested simultaneously. This approach to drug safety is first-in-class and has the potential to beneficially impact many lives.

臨床數據表明,與目前市場上的產品相比,PF614 提供的羥考酮具有更長的半衰期,Ensysce認爲這將更持續地緩解疼痛,減少重複服用短效阿片類鎮痛藥後出現的不良反應。PF614-MPAR 通過添加nafamostat將該產品提升到一個新的水平,當同時攝入過多劑量時,它會 “關閉” 羥考酮的釋放。這種藥物安全方法是首屈一指的,有可能對許多人的生活產生有益的影響。

"We are appreciative of guidance provided by the FDA to help us develop PF614-MPAR," commented Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "The fact that we have been granted Breakthrough Therapy status is a sign of the critical nature of this product. As a country, we are still losing two Americans every hour to opioid prescription overdose. My team now has an approach to attack this problem with what we believe will be a game-changing opioid analgesic that has the potential to reduce opioid overdoses while providing better control of severe acute and chronic pain. We also believe that our approach can benefit both new and existing drugs with improved therapeutic outcomes and reduced abuse."

Ensysce首席執行官林恩·柯克帕特里克博士評論說:“我們感謝美國食品藥品管理局爲幫助我們開發 PF614-MPAR 提供的指導。”“我們被授予突破性療法地位,這一事實表明了該產品的關鍵性質。作爲一個國家,我們仍然每小時因過量服用阿片類藥物處方而失去兩名美國人。我的團隊現在有了一種方法來解決這個問題,我們認爲這將是一種改變遊戲規則的阿片類鎮痛藥,它有可能減少阿片類藥物的過量,同時可以更好地控制嚴重的急性和慢性疼痛。我們還相信,我們的方法可以改善治療效果並減少濫用,從而使新藥和現有藥物均受益。”

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