Blog Exposure – FDA Approved Sage Therapeutics’ NDA Filing for the Treatment of Postpartum Depression

Stock Monitor: Acer Therapeutics Post Earnings Reporting

LONDON, UK / ACCESSWIRE / June 1, 2018 / If you want access to our free research report on Sage Therapeutics, Inc. (NASDAQ: SAGE), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=SAGE as the Company’s latest news hit the wire. On May 30, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for Sage’s lead product candidate, an intravenous formulation of brexanolone (SAGE-547) for the treatment of postpartum depression (PPD). Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Acer Therapeutics Inc. (NASDAQ: ACER), which also belongs to the Healthcare sector as the Company Sage Therapeutics. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Sage Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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What is Postpartum Depression?

Postpartum depression (PPD) is a major depressive disorder and is the one of most common medical complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within the months after giving birth. The consequence of PPD may include significant functional impairment, depressed mood and/or loss of interest in her new-born, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy, and poor self-esteem.

In the US, estimates of new mothers identified with PPD each year vary by state from 8% to 20%, with an overall average of 11.5%. Currently, there are no FDA approved therapies for PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.

About Brexanolone (SAGE-547)

Sage’s Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity provides varying degrees of desired activity instead of complete activation or inhibition of the receptor. Sage’s proprietary intravenous (IV) formulation of brexanolone is being developed for the treatment of PPD and has been granted Breakthrough Therapy Designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) in PPD.

Supporting Study

Sage’s NDA application was supported by data from the Hummingbird Program, two Phase-3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trials in the US, designed to evaluate the safety and effectiveness of brexanolone in women with moderate and severe PPD, aged between 18 and 45 years who were ≤6 months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.

Sage stated that in both trials at all doses, brexanolone achieved the primary endpoint, a significant mean reduction from baseline in the Hamilton Rating Scale for Depression total score at 60 hours compared to placebo. Brexanolone was generally well-tolerated in both studies with similar rates of adverse events (AEs) across all treatment groups.

How Breakthrough Therapy Designation is Important

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

The benefits of Breakthrough Therapy Designation include the same benefits as Fast Track Designation, plus an organizational commitment involving the FDA’s senior managers with more intensive guidance from the FDA.

The Road Ahead

The NDA was granted Priority Review status and the FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of December 19, 2018. The FDA is currently planning to hold an advisory committee meeting to discuss the brexanolone IV application.

If approved, brexanolone IV would be the first medication indicated for the treatment of PPD and would be Sage Therapeutics’ first commercial product.

Stock Performance Snapshot

May 31, 2018 – At Thursday’s closing bell, Sage Therapeutics’ stock fell 1.20%, ending the trading session at $152.69.

Volume traded for the day: 303.27 thousand shares.

Stock performance in the last month – up 3.36%; previous six-month period – up 59.04%; and past twelve-month period – up 130.96%

After yesterday’s close, Sage Therapeutics’ market cap was at $7.12 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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