March 19, 2019 7:24pm
SAGE closed down -$0.78 to $156.10 and is UP +$7.91 or 5.07% to $164.01 in the aftermarket
Zulresso is designed to reduce depression symptoms by targeting receptors of the neurotransmitter known as GABA, helping restore the normal balance in the brain that is disrupted around the time of childbirth.
The drug, ZULresso is administered as a single 60-hour intravenous infusion, is chemically identical to the hormone allopregnanolone.
Postpartum depression affects one in nine women (400,000 American women) a year. It's often treated with antidepressants, though they can take several weeks to help and don't always work.
Existing treatments include conventional antidepressants that require weeks to take full effect, psychotherapy and even shock therapy, none of which have been specifically approved for postpartum depression.
Zulresso's label will include a so-called black box warning flagging risks of excessive sedation and sudden loss of consciousness, and will only be made available through a restricted distribution program at certified facilities where the patient can be monitored for these side effects, the FDA said.
Zulresso will cost between $20 K to $34 K and that it expects reimbursement based on feedback from insurers.
Sage has another drug for postpartum depression under development, SAGE-217, that will be in far more convenient pill form. In clinical trials, it has appeared to be effective in rapidly reducing symptoms without the loss of consciousness side effect. <Multiple sources>