A primary-of-its-kind pill for postpartum depression might be available to women within the US by August.
The medication, called Zuranolone, is an antidepressant that is barely taken for 2 weeks and is in a category of medication that focus on GABA receptors — which control signaling within the central nervous system — within the brain using a substance called neurosteroid.
Sage Therapeutics and Biogen said Monday the Food and Drug Administration could approve the brand new medication by August 6.
“We see potential for zuranolone, if approved, to be a meaningful recent option that may also help address the intense unmet need faced by the various populations battling [major depressive disorder] MDD and PPD,” Dr. Priya Singhal, Biogen’s executive vp and head of research, said.
The businesses saw great leads to their trials. Within the Phase 3 SKYLARK randomized study, the scientists measured women with OOD based on the 17-item Hamilton Rating Scale for Depression (HAMD-17).
A rating of 20 or higher indicated moderate to severe depression, while a rating of zero to seven was considered “normal.”
Those with higher scores often required entry right into a clinical trial and girls were enrolled into the trial in the event that they were lower than six months post-birth and had a serious depressive episode starting in the course of the third trimester or before 4 weeks postpartum.
Women who received the Zuranolone at a 50mg dose every evening for 2 weeks had a lower HAMD rating than those that took a placebo pill.
Depression causes the neurotransmitters GABA and glutamate to be thrown off balance, which in turn affects neuron activity.
Treatments for depression typically deal with boosting serotonin levels, but research is starting to point out that the GABA receptors could also be as effective.
Zuranolone is designed to rebalance brain networks liable for mood, arousal, behavior and cognition.
The one other drug currently available to treat postpartum depression (PPD) is Zulresso, which is run through an IV repeatedly for 60 hours.
“We feel an amazing responsibility to patients with MDD and PPD to deliver a possible recent treatment option, which is so desperately needed,” Dr. Laura Gault, Chief Medical Officer at Sage, said. “Most current approved therapies may take weeks or months to work. We’re committed to advancing treatments that would help physicians and patients by addressing depression symptoms quickly.”
Around one in seven women experience PPD, in response to the National Institute of Health.
Postpartum depression could also be mistaken for “baby blues” at first — which only lasts a couple of days to per week after the infant is born — however the symptoms of PPD are more severe and last more.
Symptoms typically develop throughout the first few weeks after giving birth, but could also begin while pregnant and even as much as a 12 months after birth, in response to Mayo Clinic.
Symptoms can include crying an excessive amount of, difficulty bonding with the infant, withdrawing from family and friends, lack of interest in activities you enjoy, severe anxiety and panic attacks.
“The FDA filing acceptance and granting of priority review are necessary milestones within the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression,” Singhal said.
