The world's first pill to treat postpartum depression (PPD) is now available in the US.
The drug, branded Zurzuvae, was approved by the FDA in August to help one in seven new mothers suffering from postpartum depression.
Delivered as two tablets a day for two weeks, it could finally provide relief to millions of women who suffer from this debilitating condition each year.
But the drug comes with a high price tag — nearly $16,000 without insurance — and health officials are unsure how much insurance companies will pay.
An injectable version of the drug already exists, but it must be administered in the hospital over a 60-hour period.
Zuranolone, an antidepressant, is a once-daily pill that must be taken for two weeks. It is sold under the brand name Zurzuvae
Former Victoria's Secret model Chrissy Teigen admitted suffering from postpartum depression after the birth of her first child, saying the months following the birth were a “sad life”.
This version costs even more, coming in at $35,000.
A late-stage study of Zurzuvae in pill form found that women who took the drug had significantly better symptoms and felt better within three days than women who took a placebo, which lasted for at least 45 days.
Dr. Katrina Furey, a psychiatrist at Yale School of Medicine, said that with postpartum depression, a woman “doesn't have enough allopregnanolone and her GABA-A receptors don't fire properly, making her irritable, anxious and depressed.” among other symptoms.'
The drug, called zuranolone, belongs to a class of drugs that target GABA receptors in the brain using a substance called a neurosteroid.
It is designed to quickly rebalance dysregulated brain networks responsible for functions such as mood, arousal, behavior and cognition, thereby restoring brain function.
When a person is depressed, the two neurotransmitters GABA and glutamate become imbalanced, which affects neuron activity.
Depression treatments typically aim to increase serotonin levels in the brain, but a growing body of research shows that the GABA pathway may be just as effective.
Zurzuvae is available nationwide at specialty pharmacies that offer medications to treat rare or complex health problems. It can also be sent directly to patients.
Dr. Kristina Deligiannidis, a professor at the Feinstein Institutes for Medical Research in New York and a principal investigator in national multi-site clinical trials that led to Zurzuvae's approval, said: “Having an option like Zurzuvae that works on day 15 and the symptoms after just three days has the potential to make a profound difference in the lives of women with PPD.
Lindsay Clancy, 32, admitted killing her daughter Cora, 5, and son Dawson, 3, at the family home in Massachusetts and attacking eight-month-old baby Callan. Ms. Clancy suffered from postpartum depression
“This milestone will hopefully be a catalyst for further systemic change for women with PPD, including a much-needed expansion of screening, diagnosis and treatment across all physician specialties.”
Studies of the pill showed that its side effects were less severe than other antidepressants currently used, which can include sudden loss of consciousness, weight gain or sexual dysfunction.
Patients must obtain a prescription for the medication from their doctor, who then forwards the prescription to a specialty pharmacy.
The patient's gynecologist, midwife or family doctor can prescribe the treatment without consulting or contacting a psychiatrist.
The specialty pharmacy will then contact the patient to confirm the prescription, insurance coverage and eligibility for benefits.
The recipe will then be sent directly to you.
The Policy Center for Maternal Mental Health said it expects insurance companies and state Medicaid agencies to cover Zurzuvae because it is the only drug of its kind.
But it said there were fears the insurer could require women to have previously tried antidepressants.
Massachusetts-based drugmakers Sage Therapeutics and Biogen announced they have launched a patient support program called Zurzuvae For You.
It includes financial assistance through a copay assistance program and free medications for eligible individuals.
PPD is a condition that many women suffer from after having a child.
These involve intense feelings of sadness, fear and exhaustion that usually begin two to three days after birth and can last for months.
Other symptoms include insomnia, loss of appetite, severe irritability and difficulty bonding with the baby.
In rare cases, a serious disorder called postpartum psychosis can also develop after the birth of a child.
Existing treatments include typical antidepressants or talk therapies, but traditional antidepressants can take weeks to take effect.
The condition affects about 10 million American women and has a strong link to postpartum suicide.
According to studies, suicide is the leading cause of death in the postpartum period.
Lindsay Clancy, 32, of Duxbury, Massachusetts, admitted strangling her three children, Cora, five, Dawson, three, and Callan, eight months, to death before attempting suicide after suffering postpartum psychosis .
Ms Clancy, who worked as a midwife, reportedly suffered from postpartum depression, anxiety and psychosis.
Former Victoria's Secret model Chrissy Teigen has also admitted to suffering from postpartum depression after the birth of her first child, saying the months following the birth were a “sad life”.
It's important new research advising women to replace their medications with exercise when treating postpartum depression, which has sparked outrage among women's health experts.
The newly published analysis by researchers at the China University of Geosciences aims to prove that exercise such as running at least twice a week is more effective than traditional treatments.