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Archive for March 22nd, 2019

It’s a lot faster than current treatments, according to clinical trials.

The FDA is expected to approve the new treatment this month.

After her son was born in May 2017, Renee Raffalli suffered a massive hemorrhage, requiring six blood transfusions and a stay in the ICU. “The trauma of his birth didn’t allow me to function as a new mom in that moment,” she recalls. “I was only focused on surviving.”

For weeks, she’d cry suddenly and constantly.

“I didn’t feel like I could adequately take care of my son. I felt my husband could do a much better job than I could, therefore I started to believe I couldn’t do anything on my own,” she recalls. “Then came the overwhelming guilt. Guilt that I wasn’t focusing on him enough, that I was relying on my husband too much, that I wondered if our life would have been better if we never decided to have a kid.”

At her six-week checkup, her OB suggested she see a therapist, but she didn’t click with the one she met. She tried meeting with another therapist when her son was 10 months old, but again felt like she wasn’t getting to the root of her issues. It wasn’t until her son was 14 months old that she finally met with a psychiatrist who prescribed Lexapro.

“I feel more like myself than I have in a very long time,” she says.

Now, a new treatment for postpartum depression is on the horizon—one that promises to provide relief to struggling moms like Renee in a much shorter time frame.

The drug, called brexanolone, is expected to be approved by the Food and Drug Administration in March 2019 and will be marketed under the name Zulresso. According to Marketwatch, it would be the first drug therapy approved to specifically treat postpartum depression.

As in Renee’s case, postpartum depression is typically managed using psychotherapy and antidepressants, but those treatments can take weeks to take effect.

But results from two randomized trials of brexanolone published in The Lancet in September 2018 showed the drug could significantly improve postpartum depression symptoms within days.

“This is unlike anything we currently have available,” Samantha Meltzer-Brody, the lead author of The Lancet study and director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, told Marketwatch. “We now have an opportunity to treat women quickly, within days.”

The downside: The drug is administered by intravenous infusion over 60 hours—requiring two days of hospitalization for those who receive it. And it will likely be priced at $20,000 to $35,000 per treatment, according to Michael Cloonan, chief business officer for the drug’s maker, Sage Therapeutics Inc. However, the company is currently working with insurers to iron out coverage specifics and is looking at a launch date in June 2019, he told Marketwatch.

Given the fact that postpartum depression affects an estimated 1 in 9 women, according to the Centers for Disease Control, the new treatment could be an actual lifesaver, since severe cases of PPD can lead to suicide.

And while the pricing and intravenous delivery of brexanolone likely places it out of reach of many women, drugmakers are working on other fast-acting treatments for depression. Sage, for example, is developing an oral drug similar to brexanolone.

It’s just another way American moms are finally getting the attention they need post-delivery. Recently, the American College of Obstetricians and Gynecologists (ACOG) changed its guidelines and now recommends all women have contact with a maternal care provider within the first three weeks postpartum, followed up with ongoing care as needed and a comprehensive postpartum visit no later than 12 weeks after birth.

Renee believes more in-depth care in the weeks following her life-threatening delivery would have benefited her. “This was the most crucial time that my emotions became out of control,” she says. “By my six-week checkup, I felt as if this was my life now, my new normal, and nothing could be done.”

Hopefully, earlier and constant care, combined with new, effective medications, will help more moms like Renee get the help they need much sooner.

Source: https://www.workingmother.com/there-will-soon-be-drug-specifically-to-treat-postpartum-depression?src=SOC&dom=fb&fbclid=IwAR0ZHAjkS6R8_ceqb5vLLBdK_sj6THh_y8O-rqEdZkWW7MhZVK09SEJsH-8#page-2

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