The Food and Drug Administration approved the first drug specifically for the treatment of postpartum depression Tuesday. Sage said Zulresso is expected to be available for commercialization in June, following a scheduling meeting with the FDA.
Postpartum depression is the most common complication of pregnancy, affecting up to one in seven women who have recently given birth. Like other forms of depression, postpartum depression can cause a loss of pleasure, irritability, mood swings, racing thoughts and sadness. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads.
According to ClinicalTrials.gov, there are now 41 clinical trials underway for PPD options in Canada and the USA that are at various stages in the trial process. Those who believe it will remain a niche product do not expect sales to top $100m, while others appear to believe that Zulresso heralds a major treatment revolution, with projections soaring to $600m-plus in five years.
Studies show that without any treatment, postpartum depression can last for months or even years. "With postpartum depression, having an illness that is most likely linked to a hormonal trigger and can be treated with a hormonal therapy like [Zulresso] goes a long way toward decreasing stigma, increasing acceptance of the diagnosis, and encouraging women to seek help". For this reason, the FDA only approved Zulresso with a Risk Evaluation and Mitigation Strategy (REMS) that requires extra precautions. The treatment is to be administered as a single 60 - hour IV drip and the side effects include headache, dizziness or excessive sleepiness. You must stay in the treatment facility for that entire time and your blood oxygen levels will be constantly monitored for safety.
"With current anti-depressant SSRIs (selective serotonin reuptake inhibitors) it could take four to six weeks to get a treatment response", said Meltzer-Brody.
"I think many women who will be on this drug have to realize that they are going to be in a hospital for two-and-a-halfdays straight and be incapacitated", shesaid. The DEA schedules or classifies drugs based on their potential medical benefits compared to the risk of addiction. At the end of the 60-hour infusion, the average reduction in patients' Hamilton Rating Scale for Depression (HAM-D or depression severity score) was 17.0 points for women in the brexanolone injection 90 μg/kg/hr group, versus 12.8 in the placebo group (p 0.0001). However, many are still optimistic Zulresso will make a big difference in many women's lives.
"There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients", said Dr. Kristina Deligiannidis, who was involved in the trials and is director of Women's Behavioral Health at Zucker Hillside Hospital in NY, according to the TV network.