U.S. regulators have approved the first drug specifically developed to treat postpartum depression in women, but some experts are raising questions about the treatment’s safety.
The U.S. Food and Drug Administration (FDA) approved Zulresso -- also known as brexanolone -- an intravenous drug that must be administered in a clinical setting over 60 consecutive hours.
In clinical trials sponsored by Sage Therapeutics Inc., the company that makes the drug, brexanolone injections resulted in “significant” improvements in mothers with moderate or severe postpartum depression.
Some of those women felt their depression lift within 24 hours. At the end of the 60-hour infusion, more than 70 per cent of women had a “clinically and statistically significant response” and the effect of the treatment lasted for a month, said the psychiatrist who led the clinical trials.
“Women who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social,” Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina’s Center for Women’s Mood Disorders, told CTV News.
“Their whole demeanour really changed and their ability to interact with family and their baby also changed in a positive way. Importantly, these women reported feeling much, much better and it was a dramatic change.”
Postpartum depression can start during pregnancy or at any time up to a year after the baby is born. Symptoms include feelings of sadness, guilt, anger or worthlessness. In serious cases, some women experience suicidal thoughts.
Women with postpartum depression are normally treated with antidepressants, which can take two to four weeks to take effect. For some women with severe depression, antidepressants or psychotherapy have little effect.
The FDA has given Zulresso a “breakthrough therapy” designation, but some experts are questioning the safety of the drug.
Dr. Varuna Srinivasan, a senior fellow at the National Center for Health Research in Washington, D.C., said brexanolone has been tried in just a few hundred women so far. She hasconcerns about the results of clinical trials that are sponsored by the drug maker.
“A lot of patients … spoke about how it made a difference in their lives, but given the really small amount of patients in those trials, we didn’t really get to see the other side of the coin,” shetold CTV News. “We really don’t know the profiles of women…for whom the drug did not work.”
Srinivasan also raised concerns about the drug’s side effects, which can include sleepiness, dry mouth and loss of consciousness.
“I think many women who will be on this drug have to realize that they are going to be in a hospital for two-and-a-halfdays straight and be incapacitated,” shesaid. “They are going to be very sleepy, they are not going to understand a lot of what is happening around them, they are not going to be able to breastfeed their child [as the drug is administered].”
The FDA’s announcement of Zulresso’s approval makes it clear that patients must be strictly monitored during the treatment “because of the risk of serious harm due to sudden loss of consciousness.”
The FDA says women receiving the IV injections must have their blood oxygen levels monitored and be accompanied during their interactions with their babies or children while the drug is being administered.
“The side effects are certainly things that need to be monitored and observed,” Meltzer-Brody acknowledged.
But she said the treatment is “unlike anything else that we have available” and that the data collected in clinical trials so far has been “compelling.”
She called the FDA’s approval “the beginning of the story” and said more studies will be done to understand exactly how Zulresso works in different women.
Dr. Simone Vigod, the chief of psychiatry at Women’s College Hospital in Toronto, said she would like to know how brexanolone treatments impact a woman’s breast milk and what the long-term implications are for the mother and child.
“The question would be: does the woman have to come in again two months later or three months later and have another infusion or is that it and she is well?” Vigod told CTV News.
“I don’t think that is a reason not to proceed [with the treatment] but I think it is important to think about the fact that none of our treatments are yet a cure-all.”
Zulresso is not currently available in Canada, but may eventually be offered as part of clinical trialsbeing planned, and possibly for serious cases under the “compassionate drugsrelease” program.
“I think if it works and we can get it to a place where it was really accessible it certainly could be a very big thing,” Vigod said.
Even though the drug will be available in the U.S. in June, the drug will likely remain out of reach for many women there.Sage Therapeutics said the IV treatment will cost US$34,000 without insurance, plus the cost of staying at an infusion centre or a hospital.
With files from The Associated Press
