FDA Approves Sage Therapeutics’ Drug. “..the second new depression drug the FDA has approved in March..” By Todd Horwitz, Bubba Trading.

 

FDA APPROVES NEW DRUG.

The first drug for women suffering postpartum depression received federal approval on Tuesday, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy. The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all. 

Experts say the new treatment will provide immediate relief for mothers whose depression keeps them from providing their babies with the care, bonding and nurturing that is crucial for healthy development. As many as one in seven American women experience depression during or after pregnancy. “Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

This is the second new depression drug the Food and Drug Administration has approved in March after decades that saw no major new treatments. The agency recently cleared Johnson & Johnson’s Spravato, which works differently than older medicines to treat depression in patients who have tried previous treatments but didn’t improve.

Zulresso, also known as brexanolone, is designed to work differently than some of the older antidepressants. Studies showed that Zulresso did better at easing depressive symptoms in patients soon after dosing and when measured at 30 days after the treatment, compared with a placebo.

But the logistics and cost of the drug could limit its appeal. It is administered as a 60-hour intravenous infusion in a hospital or clinic. Sage said Tuesday it will cost $7,450 per vial, or $34,000 for a patient’s average course of therapy, before any discounts.

Dr. Kimberly Yonkers, professor of psychiatry at Yale School of Public Health, said that while the drug was effective in studies, its cost and the lengthy infusion may limit its use to the most severe cases. Sage said it based the price on the impact that the disease has on patients and society, and the clinical value of what is expected to be a one-time treatment.

Todd “Bubba” Horwitz

IN ASSOCIATION WITH

Financial Markets and Political Commentary
 

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Todd Horwitz - Author of “Average Joe Options“. Todd began his trading career in 1980 at the CBOE. He was one of the original traders in the OEX & helped start the SPX. He is a member the CME where he trades S&P futures as well as foreign currencies & is a regular contributor to CNBC, Bloomberg, BNN, Fox & many other major news networks.