'Game-Changing' Post-Natal Depression Treatment Has Been Approved
For the first time in history, the US Food and Drug Administration (FDA) has approved a drug designed specifically to treat postpartum depression (PPD), and other drug regulators are "closely watching" to see how it works.
On Wednesday, the FDA announced the approval of an intravenous (IV) infusion of the drug brexanolone to treat PPD, which can be a life-threatening illness.
It is the first therapy specifically targeting PPD. The drug, which will be sold as Zulresso, is unlike its anti-depressant predecessor.
Traditionally, selective serotonin reuptake inhibitor (SSRI) anti-depressants are prescribed to treat the serious mental illness, but it can take a month for these oral tablets to take effect.
“Having a drug approved to treat PPD that works quickly and effectively, yet is also durable, would be a huge step forward for psychiatry in general,” Samantha Meltzer-Brody, from the Department of Psychiatry at University of North Carolina, said in a statement.
Administering brexanolone through IV has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression -- which can include mood changes, weight loss or gain, sleep disturbances, negative obsessive thoughts, self-harm and crying uncontrollably.
The treatment is administered as a single 60-hour IV drip. It was found to have mild side effects, such as headache, dizziness or excessive sleepiness.
Mum-of-two Stephanie Hathaway was part of a clinical trial of the new drug, led by Meltzer-Brody, after twice grappling with PPD.
"Things that used to bring you joy now drain you. People say things meaning to help, and it ends up hurting. And you're just so hopeless," she said.
She also reported feeling better within a day after the treatment.
"The first 12 hours I didn't feel any different. I went to sleep, I woke up, and the thoughts were gone," Hathaway said.
Meltzer-Brody, who led the clinical trials, claimed the drug's approval was a "game-changing approach to treating PPD” as the effects are immediate given the first few weeks of life are such a critical time for mother and baby.
The drug will likely be priced around $20,000 to $35,000 per treatment, according to Sage Therapeutics, the company that developed the drug.
The FDA said the medication, which will will be available in June, can only be used in a restricted program and administered by a health care provider in a certified health care facility.
Will The Drug Be Available In Australia?
Anxiety and depression affect up to one in five Australian women and one in 10 men in the perinatal period. Many struggle for weeks or months before seeking help, while others never get treatment.
"Other drug regulators will be closely watching to see how it works in a clinical environment," said Professor Ian Hickie, co-director of the University of Sydney's Brain and Mind Centre.
He said he's surprised the FDA has moved so quickly to get the drug to market, given the small amount of studies to back it.
"The FDA is trying to be more focused when it comes to new therapies that behave differently and they are focusing on more immediate action, because in the past they have been criticised for wanting lots and lots of data," he told 10 daily.
"It was usually a long and cumbersome process."
Hickie said he will be watching to see if the drug has a sedative effect, given SSRIs take weeks to kick in. Doctors usually prescribe benzodiazepines -- a group of drugs known as minor tranquilisers.
"If the immediate impact is that of a sedative effect, then there are far cheaper benzo options that can be prescribed and have the same effect that don't require an IV and hospital admission," he said.
Hickie said the FDA has a "strong influence" over what other drug regulatory bodies think.
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Australia's Therapeutic Goods Administration said it cannot divulge if it has been approached by Safe Therapeutics about bringing the drug to Australia.
"Due to commercial-in-confidence considerations the TGA does not disclose information about current applications, and cannot advise whether an application has been received or is in progress," it said.
"The information that the TGA can provide about a product is publicly available on the TGA website," a spokesperson told 10 daily in a statement.
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