A medical milestone could be around the corner for treating postpartum depression as the FDA reviews a rapid acting pill developed by two Cambridge-based companies..
The FDA has granted priority review for the drug — known as Zuranolone.
Sage Therapeutics and Biogen developed Zuranolone, which is designed to treat postpartum depression and major depressive disorder.
Sage Therapeutics Chief Development Officer Jim Doherty told 7NEWS the drug provides “a short course of treatment” with a once daily dose typically taken at night for two weeks.
Close to 14 million people have been diagnosed with major depressive disorder. Five hundred thousand new moms are diagnosed with postpartum depression each year.
Researchers say the rapid treatment offered by Zuranolone is showing promising results.
“What we’re seeing is that rapid antidepressant response that occurs as early as three days after the start of treatment is maintained,” Doherty said. “The opportunity is to take a relatively short course of treatment — once a day dosing for two weeks — and then be done.”
Experts say Zuranolone is not producing common side-effects associated with other antidepressants, such as weight gain, sexual dysfunction and sleep disruption.
Researchers are hopeful the drug can be prescribed for both mild and severe cases
If approved, researchers say, Zuranolone could offer a much needed treatment for people struggling.
“We see this as an exciting opportunity for so many people who are suffering with postpartum depression and major depression,” Doherty said.
Doherty said researchers will “continue to do all the work to get Zuranlone approved as quickly as can be.”
The health agency will review the treatment for six months.
If all goes well, the drug could be approved by the end of the year.
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