First-Ever Postpartum Depression Drug Brexanolone Could Be 'Life Changing' For New Moms

Brexanolone is getting closer and closer to being approved.

It took Sara Beckel a year to recover from postpartum depression.

"It was debilitating on all fronts," Beckel told HuffPost Canada. "If brexanolone had been around, I would have said 'sign me up!'"

As a certified labour doula and founder of Family First Doula Service & Maternal Wellness in Regina, Sask., Beckel has been following the progress of brexanolone, the world's first postpartum depression drug developed by biopharmaceutial company Sage Therapeutics.

"The pain and suffering was so great that the chance to escape the daily torture of postpartum depression would have been life changing," Beckel said. "A drug like brexanolone would have given me my life back that I feel was stolen right out from under me."

Postpartum depression is common and can be debilitating

Approximately 20 per cent of women experience postpartum depression (PPD) affecting 76,000 women in Canada and 400,000 women in the United States annually. PPD results in adverse effects for the mother as well as the child and symptoms include frequent feelings of sadness, worthlessness, hopelessness, guilt, anxiety, irritability and/or anger.

Currently, when a woman presents with postpartum depression symptoms, a doctor might prescribe her an antidepressant which could take up to six weeks to take effect, if at all. She may have to switch to a different antidepressant and start the process all over again.

But in brexanolone trials, women with moderate to severe postpartum depression who were given an IV infusion over the course of 2.5 days revealed dramatic improvements within 24 hours that lasted for 30 days, the length of time researchers monitored the women for their study.

What is brexanolone?

The drug is a synthetic form of allopregnanolone, a hormone which increases in women during pregnancy then drops dramatically following child birth.

The decline in hormones following labour — including estrogen, progesterone, and in particular allopregnanolone — and its adverse effect on the brain's neurotransmitters in some women is one of the prevailing theories into the cause of postpartum depression.

Though the mechanism of action isn't entirely known, providing brexanolone to women suffering from postpartum depression works to help fill the gap created by the sudden loss in allopregnanolone.

"The idea that you could potentially have a drug that could have women treated very quickly within days, which is very different than what's currently available would be a paradigm shift that would be extremely exciting for the field," Brexanolone Academic Principal Investigator Samantha Meltzer-Brody, who is also the director of the Perinatal Psychiatry Program at The University of North Carolina in Chapel Hill, told HuffPost Canada.

"From a women's mental health perspective, that's a big deal."

The drug is currently under review by the U.S. Food and Drug Administration and if approved, could be on the market as early as 2019. Brexanolone also looks promising in Europe, having received the Priority Medicines designation from the European Medicines Agency, a designation to "enhance support for the development of medicines that target an unmet medical need."

So, when is it coming to Canada?

"We are not providing specific guidance on our global regulatory strategy," Sage Therapeutics Senior Director Jeff Boyle told Huffpost Canada, "but we are taking a thoughtful, step-wise approach that supports broad registration for this potentially transformative medicine."

Simone Vigod, a psychiatrist and lead of the Reproductive Life Stages Program at Women's College Hospital in Toronto, has been closely following brexanolone's progress. She believes the science has been promising, though she would like to see more research on it before its use becomes widespread.

"Samples in the published randomized trial were small, so it would be useful to see replication," Vigod told HuffPost Canada. "Also, it will be important to see the results for women with less severe depression with postpartum onset, and whether there will be benefit for women who have postpartum depression but for whom the onset was not perinatal."

Results so far have been promising

Results of Sage Therapeutic's "significant and clinically meaningful" phase two findings involving 21 women were published last summer in The Lancet. Women less than six months postpartum with severe postpartum depression were randomly assigned to receive either brexanolone or a placebo treatment for 60 hours. Women were not permitted to breastfeed while receiving treatment.

Using the Hamilton Rating Scale for Depression (HAM-D), researchers found that in the women who received brexanolone, scores decreased by 21 points. In women who received the placebo, HAM-D scores decreased by eight points. Side effects included dizziness and drowsiness.

The results of two phase three brexanolone trials were recently revealed. In the first trial of 100 women with moderate PPD, brexanolone was shown to reduce HAM-D scores by 14.2 points versus 12 points in women who were given a placebo.

In the second trial of 138 women with severe PPD, brexanolone was shown to reduce HAM-D scores by 19.9 points with a low dose of the drug and by 17.7 points with a high dose of the drug versus 14 points in women who were given a placebo.

Common side effects included headaches, dizziness, drowsiness, and infusion site pain.

"Larger numbers will increase confidence around safety, including implications for safety in lactation," Vigod said. "Novel, safe, effective treatments that are accessible and acceptable to postpartum women would go a long way to improving health of mothers, children and their families."

"It could be life changing"

After going through postpartum depression, Beckel became a staunch maternal mental health advocate and is one of the lead organizers behind the first annual Our Mothers, Our Future conference in Saskatoon.

While she hopes Canada will one day approve brexanlone, Beckel is concerned about potential challenges in administering the drug as well as cost. It's been estimated that the cost could amount to $15,000 to $20,000 per treatment.

"Not having facilities set up to room mom and baby in Canada while the mother is being treated is a big challenge and if approved, would it be covered completely? If not, I'm assuming the cost would be extremely high, making it unavailable to most," Beckel said.

"On the flip side, it could mean everything to a suffering mom. It could be life changing. This new drug would eliminate the need to chase down the right medication," Beckel said.

"It took me a year to start feeling better. That's a lot of wasted time that my kids didn't have with a healthy mom."

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