制药巨头强生公司最近透露，公司正在进行的利用善思达进行3个月疗程治疗精神分裂症的三期研究进展顺利。在这项从去年春天开始进行的研究中，总计509名患者在首先接受一个月疗程的善思达治疗稳定病情后，再随机给予三个月疗程善思达药物或者安慰剂。结果显示，新剂型对患者病情稳定表现良好。强生公司随后宣布，公司计划在今年晚些时候将其提交FDA审核。
神经科学一向是生物制药领域的雷区，失败率相当之高。此次研究如能顺利通过，对强生公司是一个不小的激励。另一家生物技术公司Alkermes公司也参与了这项研究，为善思达提供载药系统。
J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J ($JNJ) as well as Alkermes ($ALKS), which provided their NanoCrystal delivery tech for the new-and-improved therapy.
In the study schizophrenic patients were initially stabilized with the one-month formulation of Invega Sustenna (paliperidone palmitate) and then randomized to either a placebo or the three-month formulation as patients were observed on the time interval to their next relapse. The study launched last spring with 509 patients. The international study was concluded after investigators were able to distinguish a statistically significant difference between the two arms after the first 42 relapses were noted.
J&J says it's on track to get the 3-month formulation NDA to the FDA later this year.
Neurosciences has proven to be a minefield for drug developers in recent years, but a me-better drug like this could expect to go into a new Phase III with a better formulation holding high odds for success. Alkermes has specialized in developing longer-lasting formulations of drugs for diabetes and neuroscience drugs. The company acquired the NanoCrystal tech when it bought out Elan's drug delivery tech unit for close to a billion dollars three years ago. And it's been working on new-and-improved drugs of its own in this area of R&D.
"We are really excited ab0ut this news because a medication's ability to delay time to relapse in schizophrenia has significant clinical and societal implications," said Husseini Manji, who heads up Janssen's neuroscience R&D efforts, in a statement. "Being able to delay relapse can prove to be beneficial clinically to patients, to their caregivers and to the community."
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