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UC Davis research leads to first drug specifically for postpartum depression

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UC Davis, on August 8, 2018, announced that along with Kindred Healthcare, it will construct and operate a second hospital on its downtown Sacramento campus to provide rehabilitation services for stroke, spinal cord and brain trauma patients.
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UC Davis, on August 8, 2018, announced that along with Kindred Healthcare, it will construct and operate a second hospital on its downtown Sacramento campus to provide rehabilitation services for stroke, spinal cord and brain trauma patients.

Federal regulators have approved the first drug treatment specifically for women with postpartum depression, an innovation made possible because two UC Davis Health researchers took a closer look at a steroid that has anti-depressant potential, the health system announced late Thursday.

The University of California licensed UCD’s patented discovery to publicly traded Sage Therapeutics, a biopharmaceutical company based near Boston, and the company’s share price has risen since March 19 when it reported that the U.S. Food and Drug Administration had approved sales of the new drug Zulresso.

In clinical trials, the treatment significantly reduced depression for women who received the drugs, compared with women who received a placebo, according to Sage’s news release. Patients experienced relief as early as 24 hours, and that effect was maintained through a 30-day follow-up. Researchers chose a widely used screening tool known as the Hamilton Depression Rating Scale to measure levels of depression.

Roughly one in every nine U.S. women who give birth will experience postpartum depression, according to statistics from Sacramento-based UCD Health, and more than half of them may go undiagnosed without proper screening. Women who have postpartum depression experience symptoms such as anxiety, irritability, sadness, withdrawal from friends or family, and trouble bonding with their newborn. They also may think of harming themselves and, in rare cases, their children.

Dr. Michael Rogawski, a neurologist and pharmacologist at UC Davis Health, said he and other researchers around the nation had observed that a naturally occurring steroid called allopregnanolone had the potential to lift depression. However, he said, the amount of the steroid in a woman’s system was closely tied to her production of progesterone.

“Blood levels of progesterone, and therefore allopregnanolone, rise dramatically as pregnancy progresses, but begin to decrease in late pregnancy and then fall precipitously during the day or two after giving birth,” Rogawski said. “I reasoned that allopregnanolone levels might also fall and I hypothesized that the withdrawal of this endogenous antidepressant substance could trigger depression for some women. This led to the discovery of allopregnanolone as a treatment for postpartum depression.”

Rogawski worked closely with UC Davis project scientist Dorota Zolkowska, and the two are listed as inventors on the patent issued April 9 to the UC Board of Regents. Typically, a company such as Sage will pay UCD for things such as patent costs, licensing fees and a percentage of sales as an ongoing royalty, figures that UCD said are confidential. Inventors also receive a share of any income the university receives.

In fiscal 2017, the most recent year for which there was data, the University of California’s top-earning drug treatments included a prostate cancer drug that grossed royalties and fees of $29.5 million and cellular immunotherapies that brought in $890,000.

A medical provider must monitor patients receiving Zulresso, which contains a synthesized version of allopregnanolone, and it is administered through an intravenous infusion over a 60-hour period. The most common adverse events experienced by patients in the studies were sleepiness, dry mouth, loss of consciousness and flushing.

To receive FDA approval, Sage had to do three trials with subjects at multiple centers to evaluate the safety and effectiveness of Zulresso. Neither individuals administering the drug nor those taking them knew whether patients were getting Zulresso, a placebo or an alternate treatment.

In the trials, UCD said, researchers chose women between ages 18 and 45 who had been diagnosed with moderate to severe postpartum depression within six months of their screening. The subjects also had experienced symptoms no earlier than the third trimester and no later than the first four weeks following delivery.

Sage’s leaders said they expect sales of Zulresso to launch in late June, after the U.S. Drug Enforcement Administration has completed its classification process.

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