贝尔海文生物制药获得FDA批准进行无针纳斯德皮鼻上腺素治疗过敏症的关键试验. Belhaven Biopharma gets FDA go-ahead for pivotal trial of needle-free Nasdepi nasal epinephrine for anaphylaxis.

Belhaven Biopharma已获得林业发展局批准,开始对Nasdepií(BBP01)进行关键研究测试,这是调查性鼻粉肾上腺素治疗,作为无针麻醉剂的替代方法。 Belhaven Biopharma has received FDA approval to begin a pivotal study testing Nasdepi® (BBP01), an investigational nasal powder epinephrine treatment, as a needle-free alternative for anaphylaxis. 随机交叉试验将把Nasdepi 4.5毫克的剂量与标准0.3毫克的肌肉内肾上腺素注射和自动注射器进行比较,评估血液、生理反应和安全中的药物水平。 The randomized, crossover trial will compare Nasdepi 4.5 mg to standard 0.3 mg intramuscular epinephrine injections and autoinjectors, assessing drug levels in the blood, physiological responses, and safety. 这项研究遵循了加拿大先前的试验,并支持Belhaven的目标,即通过一种能帮助因恐惧、成本或复杂性而避免传统自动注射器的病人的热稳定、易于使用的鼻腔配方,改善肾上腺素的获得途径。 The study follows prior trials in Canada and supports Belhaven’s goal of improving access to epinephrine through a heat-stable, easy-to-use nasal formulation that could help patients who avoid traditional autoinjectors due to fear, cost, or complexity.