Tuesday, October 14, 2014 9:50:05 AM
Trial results
A Phase 3 trial in AGHD has been completed. The parameters of the study were achieved as agreed to with the FDA under a Special Protocol Assessment (SPA). Importantly, the primary efficacy parameters showed that the study achieved both specificity and sensitivity at a level of 90% or greater. The use of MacrilenTM was shown to be safe and well tolerated overall throughout the completion of this trial.
Development plan
A new drug application (NDA) to the FDA in AGHD is currently under review with a Prescription Drug Use Fee Act (PDUFA) date of November 5th 2014. MacrilenTM could become the first orally approved product to evaluate AGHD. It is also currently in a Phase 2A investigator-driven trial as a treatment for cancer cachexia.
Partnership status
Aeterna Zentaris owns the worldwide rights to MacrilenTM.
http://www.aezsinc.com/en/page.php?p=20&prod=43
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