The top doctor of a $2.7 billion pharmaceutical company developing a new drug for depression says we may be ‘on the brink’ of a new wave of mental health treatments

Sad young woman sitting on the window and looking outside

Sad young woman sitting on the window and looking out – stock photoTunatura/Getty Images

  • Most depression treatments do not work quickly and are intended for long-term use.

  • Sage Therapeutics is developing a fast-acting drug that patients take for two weeks.

  • Dr. Laura Gault told Insider that psychiatry is about to have new and better drugs.

Years ago, Big Pharma had all but left psychiatry behind. After conducting large, disappointing failed trials that they hoped would lead to new and profitable treatments, major companies folded their ambitious plans.

But smaller biotech companies got stuck in research and development, hoping to create better treatments.

And now their work can bear fruit.

So says Laura Gault, the chief medical officer at Sage Therapeutics, a Massachusetts-based company that is developing a new antidepressant called zuranolone. The company recently asked U.S. regulators to approve the drug as a treatment for people with postpartum depression and major depressive disorder, citing data that the drug improved symptoms of those conditions in patients.

“Psychiatry is really on the cusp of having new drugs that are really effective and work in different ways than we’ve had,” Gault said.

Laura Gault, the chief medical officer at Sage Therapeutics.

Laura Gault, the chief medical officer at Sage Therapeutics.Sage therapies

Gault said that as a result of the research mental health professionals have been conducting in recent years, we now have a better understanding of depression and other psychiatric disorders. These advances in science, she said, can now be translated to clinical trials.

“It’s really exciting to see and I’m hopeful that in the next five to 10 years we will see a resurgence of new approaches, new treatments and effective treatments for patients with psychiatric conditions,” she told Insider.

Sage is developing zuranolone through a collaboration with the biotech company Biogen. Last week, the companies announced that the Food and Drug Administration will make a decision on August 5 whether to approve the treatment.

Sage’s stock is up 7.9% over the past 12 months, giving the company a market value of approximately $2.7 billion.

Unlike most other antidepressants, zuranolone is designed to be taken for a short period of time

In studies, zuranolone has improved symptoms of major depressive disorder and postpartum depression. The drug is designed as an episodic treatment, meaning patients take the pill once a day for two weeks and then stop.

Most antidepressants on the market today are thought to work by stimulating the activity of neurotransmitters, or chemical signals in the brain that affect mood and emotions. Zuranolone works differently. Rather than affecting neurotransmitters, the drug affects the GABA-A receptor in the brain, which may play a role in depression.

Zuranolone has been tested in seven studies for both major depressive disorder and postpartum depression. While a late-stage trial to test the drug in MDD patients failed in 2019, a similar trial in 2021 called WATERFALL showed that the drug helped improve depression symptoms compared to a placebo.

If approved, zuranolone would join a busy marketplace of generic antidepressants. Chris Benecchi, Sage’s chief business officer, said despite the competition, he believes zuralonone will be an attractive option, especially for patients whose current treatment regimens aren’t working. About a third of people who try antidepressants don’t get better.

“The sooner we can intervene and help a patient achieve a response and remission, the better the long-term outcomes for that patient,” Benecchi said. He declined to say how much zuranolone will cost.

Episodic treatment can ‘make a huge difference in patients’ lives’

Sage therapies

Sage Therapeutics is developing a new antidepressant that the FDA could approve as early as August.Sage therapies

Some analysts have noted that there are still open questions about how long the drug’s effects may last and what dose of the drug works best for patients.

Analysts for William Blair said in a Feb. 6 note that the “marginal benefits” shown by zuranolone in studies may limit the drug’s appeal to patients compared to existing treatments.

In a late-stage study, researchers followed 489 patients — whose depression symptoms improved with zuranolone — for a year. They found that about a quarter of patients needed one additional course and 30% needed three or more courses.

The researchers used two common tests to determine whether a participant became depressed again and needed another course of treatment.

Sage said the median time patients underwent a repeat course after their first treatment was 135 days. Gault added that for participants who received a higher dose of zuranolone, the median time to retreatment was extended to 249 days.

Gault said undergoing a two-week course of treatment and having those effects last for months before receiving an additional course of therapy “makes a huge difference in patients’ lives.”

Read the original article on Business Insider

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