- 研究结果鼠尾草和生物原在星期二披露, however, were mixed. While treatment with the drug showed a greater effect than placebo, the benefit appeared to wane over time. The difference between groups on an important secondary goal of the study, meanwhile, was not statistically significant. Treatment was associated with higher rates of side effects like drowsiness and sedation.
- In a statement, the companies said they would discuss their findings with the Food and Drug Administration. The trial is the most important of several studies that Sage executives previously said they hoped could support an approval of zuranolone. Investors, however, seem to have doubts, sending Sage shares down by double digits in pre-market trading Tuesday.
Sage has also hoped testing would show zuranolone to be safer than existing drugs for depression, some of which come with warnings about the risk of suicidal thoughts and behaviors.
但圣人遇到了毒品的价值。第3阶段研究2019年底失败了, forcing the company to change up its plans for clinical development. Such setbacks are not uncommon for psychiatric drugs; many have won approval despite mixed clinical results, and developers often struggle to deal with strong placebo responses.
圣人设计了2019年令人失望的新阶段3次试验，使其几种新的路径将药物带到监管机构。药物的潜力吸引生物原性，这签署了多亿美元的交易with Sage last November to gain access to it and a treatment for essential tremor.
"We'll sit down with the agency to map out next steps, and we'll share updates in the coming months," said Sage's CEO Barry Greene, who joined the company in December, on a conference call Tuesday.
但是，治疗效果在第3天最大，并且在每次到第15天测量的每个时间点都会衰退。关于另一种评级规模，称为CGI - 严重程度，祖兰松和安慰剂之间的差异在统计学上没有统计学意义。虽然贤者表示，在第42天保持反应的研究参与者中，药物和安慰剂之间的差异也不是在第42天保持反应的份额。据贤者表示，有一个有限的优势，有利于祖兰松。
Mizuho analyst Vamil Divan, for instance, noted that experts he’s spoken with had been looking for at least a 3-point difference between drug and placebo. Though patients retained most of the treatment benefits after 42 days, "that is not relevant in our opinion if initial efficacy is so limited," Divan wrote. Even if approved, "we think the commercial outlook for the product would be quite limited," he added.
但这可能取决于部分意图的速度有多快l-world patients need additional treatment with zuranolone or another drug to deal with their depression. Greene noted that 70% of patients treated in a study called SHORELINE needed only one or two treatment courses to "maintain wellness" over a year. If so, wrote Stifel analyst Paul Matteis, "that trumps the relevance" of the durability data.
On safety, zuranolone was associated with greater side effects than placebo, particularly drowsiness, dizziness, sedation and headache. Encouragingly, there were no signs of withdrawal or suicidal ideation, Sage said. Fewer patients treated with zuranolone dropped out of the trial, an important factor for antidepressant studies.
Called WATERFALL, the trial enrolled 543 adults between 18 and 64 years old. The dose of zuranolone tested, 50 mg, was higher than the two doses studied in the clinical trial which failed in 2019.