Very good news from SAGE Therapeutics this morning. The FDA has agreed to give SAGE Therapeutics an expedited pathway for oral drug SAGE-217 for the indications of Postpartum Depression (PPD) and Major Depressive Disorder (MDD). Below is copied directly from the press release this morning.
- Expedited SAGE-217 development plan to support potential NDA submission for MDD and PPD together
- Previously completed placebo-controlled study in MDD considered as pivotal; initiation of one additional Phase 3 pivotal trial anticipated in 2H of 2018
- Ongoing study in PPD designated as pivotal; results expected in 4Q 2018
- If successfully developed, SAGE-217 has the potential to be the first durable, rapid-acting, oral, short-course treatment for MDD and PPD
The second half of 2018 will be packed with clinical trial data for PPD and MDD. SAGE-217 is an oral once daily delivered drug with patent to April 2034. Thank you for reading.
