The FDA has approved zuranolone (Zurzuvae, Sage
Therapeutics) as the first oral medication to treat postpartum depression (PPD)
in adults.
United Kingdom: On Monday, 7th August
2023, Zurzuvae was approved by the US Food and Drug Administration as the nation's
first oral treatment for Postpartum Depression (PPD). Before this approval, the
only way to treat postpartum depression with medication was to get an IV
injection from a healthcare provider in some places. The pill, zuranolone,
which will be marketed under the brand name Zurzuvae, was developed by Sage
Therapeutics, a Massachusetts company that produces it in partnership with
Biogen. It is expected to be available after the Drug Enforcement
Administration completes a 90-day review required for drugs affecting the
central nervous system, Sage said. The companies have not announced a price for
the pill. Now, zuranolone (Sage Pharmaceuticals) is the first and only
medication that can be given orally once a day to help with postpartum
depression. The approval was based on the results of two clinical trials, the
ROBIN (Randomized, Double-Blocked, Placebo-Controlled) and the SKYLARK
(Platelet-Initiated, Randomized, and Placebo-Initiated) studies. In the ROBIN
study, women who had experienced postpartum depression were given 50 mg
zuranolone daily for 14 days. Compared to the placebo groups, the zuranolone
group showed significantly more improvement in symptoms. The effects were
maintained for 42 days following the last dose. Zuranolone is a neuroactive
steroid — a synthetic hormone that gets synthesized in the brain and helps
regulate mood and behavior. The drug acts on GABA receptors, chemical
messengers thought to play a role in regulating fear, anxiety and stress.
A boxed warning has been added to the drug's label by the Food and
Drug Administration (FDA), which states that it "may affect a patient's
ability to drive or engage in other activities that may be hazardous to their
health." Patients may not have the ability to determine their level of impairment.
The FDA recommends that patients avoid driving or operating heavy machinery for
a minimum of 12 hours after using the drug.
The most common side effects listed by the FDA are drowsiness,
feeling dizzy, diarrhea, feeling tired, having a sore throat, and having a
urinary infection. The FDA also said that using the drug could lead to suicidal
thoughts and behavior, as well as fetal harm. They also said that women should
use good contraception while taking the drug and for a week after taking it.
It’s estimated that each year in the United States, more than 400,000 babies
are born to mothers who are depressed. Postpartum depression can take anywhere
from a few weeks to months or even years without treatment, according to the
National Institute of Mental Health (NIMH). The Food and Drug Administration
(FDA) has approved zuranolone as a New Drug Application (NDA) for treatment of
adults with Major Depressive Disorder (MDD). However, the CRL indicated that
the application does not provide sufficient evidence of effectiveness to
support its approval for MDD treatment and that further studies will be
necessary.
According to the M.D., acting director of the Division of
Psychiatry Products in the FDA’s Center for Drug Evaluation and Research ,
“Postpartum depression is a serious condition that, when severe, can be
life-threatening. Women may experience thoughts about harming themselves or
harming their child. Postpartum depression can also interfere with the
maternal-infant bond. This approval marks the first time a drug has been
specifically approved to treat postpartum depression, providing an important
new treatment option. Because of concerns about serious risks, including
excessive sedation or sudden loss of consciousness during administration,
Zulresso has been approved with a Risk Evaluation and Mitigation Strategy
(REMS) and is only available to patients through a restricted distribution
program at certified health care facilities where the health care provider can
carefully monitor the patient.
According to M.D., Ph.D., Chief Medical Officer at Sage
Therapeutics, “We feel a tremendous responsibility to
patients with MDD and PPD to deliver a potential new treatment option, which is
so desperately needed. Most current approved therapies may take weeks or months
to work. We are committed to advancing treatments that could help physicians
and patients by addressing depression symptoms quickly. We believe zuranolone,
if approved, could offer a new way for physicians to support patients.”
”According to TechSci Research, the
approval of zuranolone is likely to lead to an increase in the demand for
treatment for postpartum depression. This, in turn, is likely to drive growth
in the pharmaceutical market. It could lead to the development of new drugs for
postpartum depression. Pharmaceutical companies may be more likely to invest in
research and development of new drugs for postpartum depression if they see
that there is a demand for such drugs. The approval of zuranolone could help to
raise awareness of postpartum depression among doctors, patients, and the
general public. This could lead to more women being diagnosed and treated for
the condition. It is a promising new treatment for postpartum depression. If it
is successful, it could improve the treatment of the condition and reduce the
number of women who suffer from it. The approval of zuranolone is a major coup
for Sage Therapeutics and Biogen. It establishes the companies as leaders in
the development of new treatments for mental health disorders. This could help
them to attract more investors and partners, and to secure funding for future
research and development. The success of zuranolone could encourage Sage
Therapeutics and Biogen to invest more in research and development. The
companies may be more likely to fund research into new treatments for mental
health disorders, as they have seen the potential of this market.