麻豆传媒

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鈥檚 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 injectionsin 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 鈥渃linically and statistically significant response鈥� and the effect of the treatment lasted for a month, said the psychiatrist who led the clinical trials.

鈥淲omen who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social,鈥� Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina鈥檚 Center for Women鈥檚 Mood Disorders, told 麻豆传媒.

鈥淭heir 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.鈥�

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 鈥渂reakthrough therapy鈥� 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.

鈥淎 lot of patients 鈥� spoke about how it made a difference in their lives, but given the really small amount of patients in those trials, we didn鈥檛 really get to see the other side of the coin,鈥� shetold 麻豆传媒.  鈥淲e really don鈥檛 know the profiles of women鈥�for whom the drug did not work.鈥�

Srinivasan also raised concerns about the drug鈥檚 side effects, which can include sleepiness, dry mouth and loss of consciousness.

鈥淚 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,鈥� shesaid. 鈥淭hey 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].鈥�

of Zulresso鈥檚 approval makes it clear that patients must be strictly monitored during the treatment 鈥渂ecause of the risk of serious harm due to sudden loss of consciousness.鈥�

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.

鈥淭he side effects are certainly things that need to be monitored and observed,鈥� Meltzer-Brody acknowledged.

But she said the treatment is 鈥渦nlike anything else that we have available鈥� and that the data collected in clinical trials so far has been 鈥渃ompelling.鈥�

She called the FDA鈥檚 approval 鈥渢he beginning of the story鈥� 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鈥檚 College Hospital in Toronto, said she would like to know how brexanolone treatments impact a woman鈥檚 breast milk and what the long-term implications are for the mother and child.

鈥淭he 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?鈥� Vigod told 麻豆传媒.

鈥淚 don鈥檛 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.鈥�

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 鈥渃ompassionate drugsrelease鈥� program.

鈥淚 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,鈥� 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