Health chiefs are about to approve the first ever pill designed specifically for women with postpartum depression.
Massachusetts-based drugmakers Sage Therapeutics and Biogen said Monday that the Food and Drug Administration (FDA) could approve the drug by August 6.
The drug Zuranolone is an antidepressant that patients only need to take for two weeks. This is in stark contrast to the other postpartum depression (PPD) medicine on the market, a drug called Zulresso that must be administered intravenously for 60 hours continuously.
Postpartum depression affects about one in seven new mothers. Symptoms can be debilitating, ranging from deep distress and frequent crying to thoughts of hurting the baby, feeling separated from the baby or feeling like your baby belongs to someone else.
More attention has been drawn to the condition in recent weeks after Boston mother Lindsay Clancy, 32, allegedly killed her three children after suffering from an extreme form of postpartum psychosis.
Health chiefs close to approving first-ever pill designed specifically for women struggling with postpartum depression (file photo)
Postnatal depression is widespread – around one in seven new mothers suffer from it. And it can be treated with medication and talk therapy.
Dr. Priya Singhal, Biogen’s Executive Vice President and Chief Research Officer, said Monday: “We see the potential for zuranolone, if approved, as a viable new option that can help address the severe unmet need faced by the various population groups , to address. . [major depressive disorder] MDD and PPD.”
“The FDA approval and grant of priority review are important milestones in the shared mission of Biogen and our collaboration partner Sage to advance the understanding and treatment of depression.”
Zuranolone belongs to a class of drugs that use a substance called a neurosteroid to target GABA receptors in the brain.
It is designed to rapidly rebalance dysregulated brain networks responsible for functions such as mood, arousal, behavior and cognition to help restore brain function.
When a person is depressed, GABA and glutamate, both neurotransmitters, become imbalanced, affecting neuron activity.
Was Massa’s mother charged with murder and did she suffer from PPD?
Police are investigating the possibility that 32-year-old Lindsay Clancy, accused of killing her young children before attempting suicide, was suffering from postpartum anxiety and psychosis when she committed the crimes.
Treatments for depression usually focus on increasing levels of serotonin in the brain, but a growing body of research shows that the GABA pathway can be just as effective.
The drug companies are seeking FDA approval based on their five studies in MDD and two studies in PPD. In the randomized phase 3 SKYLARK study, women who received the drug at a dose of 50 mg felt measurably better after three days.
They measured women with PPD based on the 17-item Hamilton Rating Scale for Depression (HAMD-17). A score of zero to seven is considered normal, while a score of 20 or higher (indicating at least moderate severity) is usually required for participation in a clinical trial. Women were included if they were less than six months postpartum and had a major depressive episode that began during the third trimester or before four weeks postpartum.
Women who received zuranolone every night for two weeks experienced greater reductions in HAMD levels than women who received a placebo pill. On Day 15, the mean decrease in HAMD scores was 15.6 in women receiving zuranolone versus 11.6 in the placebo group.
At day 45, women treated with zuranolone still had a greater reduction in HAMD scores than women receiving placebo (17.9 points and 14.4 points lower, respectively).
Dr. Laura Gault, Chief Medical Officer at Sage, said: “We feel a tremendous responsibility to patients with MDD and PPD to provide a potential new treatment option that is so desperately needed. It can take weeks or months for most currently approved therapies to work. We are committed to advancing treatments that can help doctors and patients by quickly addressing symptoms of depression.”
Postpartum depression should not be confused with the “baby blues”, a common postpartum phenomenon characterized by mood swings, depression and crying. It usually occurs a few days after birth and can last for several weeks.
Lindsay Clancy (32) is accused of killing her daughter Cora (5) and son Dawson (3) at the family home in Massachusetts and assaulting the eight-month-old baby Callan. Pictured L-R: Lindsay, Dawson, Corey and husband Patrick
In more extreme cases, a new mother can suffer postpartum psychosis, the condition in which Mrs. Clancy believes was when she committed the murders. This is a rare condition that usually develops within the first week after birth. A new mother with psychosis will have an altered experience of reality that will affect her ability to function normally.
Postpartum psychosis prone to paranoia, dramatic mood swings, hallucinations, delusions and suicidal and/or homicidal thoughts is treatable. An array of antidepressants are available to mental health professionals. The drug does not need to be tailored to PPD symptoms to work. Talk therapy is also a useful tool for millions of women struggling after pregnancy.
Source link
Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
