Top Physician at $2.7 Billion Drug Company Developing New Depression Drug Says We May Be ‘On the Cusp’ of a New Wave of Mental Health Treatments

• Most depression treatments don’t work quickly and must be taken for long periods of time.

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

• Dr. Laura Gault told Insider that psychiatry is on the verge of having new and better medicines.

Years ago, Big Pharma had all but left psychiatry behind. After embarking on large, disappointingly botched studies that they hoped would lead to lucrative new treatments, big companies abandoned their ambitious plans.

But smaller biotech companies have continued to focus on research and development, hoping to create better treatments.

And now, their work could pay off.

That’s according to Laura Gault, chief medical officer of Sage Therapeutics, a Massachusetts-based company working to develop a new antidepressant drug, called zuranolone. The company recently asked US 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 disorders in patients.

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

Gault said that as a result of research mental health professionals have conducted in recent years, we now have a more sophisticated understanding of depression and other psychiatric disorders. These advances in science, he said, can now be translated into clinical trials.

“It’s really exciting to see and I’m really hopeful that in the next 5 to 10 years we will see a resurgence of new approaches, new treatments and effective treatments for patients with psychiatric illness,” he told Insider.

Sage is developing zuranolone through a partnership with biotech company Biogen. Last week, the companies announced that the Food and Drug Administration would make a decision on approving the treatment by Aug. 5.

Sage’s shares are up 7.9% in the past 12 months, giving the company a market value of about $2.7 billion.

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

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

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

Zuranolone was tested in seven trials for both major depressive disorder and postpartum depression. While a late-stage study testing the drug in patients with MDD failed in 2019, a similar study in 2021, called WATERFALL, showed the drug helped improve symptoms of depression compared to a placebo.

If approved, zuranolone would join a crowded generic antidepressant market. Chris Benecchi, chief business officer at Sage, said that despite the competition, he believes zuranolone will be an attractive option, especially for patients whose current regimen isn’t working. About a third of people who try antidepressant treatments don’t get better.

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

Episodic treatment could make ‘huge difference in patients’ lives’

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

William Blair analysts said in a Feb. 6 note that the “marginal benefits” zuranolone has shown in studies could limit the drug’s appeal to patients, compared with existing treatments.

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

The researchers used two common tests to determine if a participant was becoming depressed again and needed another round of treatment.

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

Gault said going through a two-week 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