Sage Therapeutics Inc. said on Monday its oral treatment for postpartum depression met the main goal of reducing symptoms of the condition, when compared to a placebo in a late-stage study. Patients treated with SAGE-217 showed an improvement in the Hamilton Rating Scale for Depression (HAMD-17) that scores to patient on 17 different parameters, including anxiety and insomnia, the study results showed.
Postpartum depression (PPD), also called postnatal depression, is a type of mood disorder associated with childbirth, which can affect both sexes. Symptoms may include extreme sadness, low energy, anxiety, crying episodes, irritability, and changes in sleeping or eating patterns. Onset is typically between one week and one month following childbirth. PPD can also negatively affect the newborn child.
Physical and Emotional Factors
While the exact cause of PPD is unclear, the cause is believed to be a combination of physical and emotional factors.These may include factors such as hormonal changes and sleep deprivation.Risk factors include prior episodes of postpartum depression, bipolar disorder, a family history of depression, psychological stress, complications of childbirth, lack of support, or a drug use disorder.
Diagnosis is based on a person's symptoms. While most women experience a brief period of worry or unhappiness after delivery, postpartum depression should be suspected when symptoms are severe and last over two weeks. After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points on the HAMD-17), compared to 13.6 for placebo (p = 0.0029), with statistically significant reductions in HAMD-17.
Compared to placebo maintained through the end of the four-week follow-up, the company said in a statement. The results come months after the US Food and Drug Administration extended the review of the Massachusetts-based drug developer's lead drug Zulresso, an injectable that aims to treat postpartum depression, by three months.
Certain patients who were on Zulresso experienced loss of consciousness, which was flagged as a safety concern by FDA staff reviewers as well as members of an advisory panel to the health regulator during a meeting in November.
However, there were no reports of such a loss of consciousness in SAGE-217 trial. SAGE-217 was well-tolerated, but one patient in each group discontinued treatment because of a side effect, the company said. "SAGE-217's profile is highly encouraging and qualitatively looks cleaner to what one might observe / glean from the FDA label of other oral GABA drugs, such as Xanax," Matteis wrote in a note.