Sage Therapeutics is trying to pick up pieces of the depression market that have long been left behind, including patients who are not fully served by existing meds and postpartum mothers who have never had an easy, fast option to try.
The company completed a filing for Biogen-partnered zuranolone in major depressive disorder (MDD) and postpartum depression (PPD) at the end of 2022. The former indication is one that has had few new options in recent years, and the latter has never had a fast-acting treatment. Addressing the audience at the J.P. Morgan Healthcare Conference, Sage CEO Barry Greene ticked off the list of attributes he hopes will put zuranolone over existing meds, specifically its oral form and fast-acting nature.
Greene and Chief Business Officer Chris Benecchi also dismissed the suggestion that PPD is a “niche” indication, saying that there are 500,000 mothers diagnosed with the condition each year, or 1 in 8 live births. These patients have no existing oral treatment options.
“We know that there's profound impact not only on those moms but on those families as well, too,” Benecchi said. “We believe that with zuranolone, there is significant opportunity to really introduce this medication and with approval to really push for earlier first-line use with the medication. That's absolutely paramount.”
Sage has experience in PPD through Zulresso, which was approved in March 2019 for the condition. But the therapy carries a boxed warning of excessive sedation or sudden loss of consciousness during administration, so it must be administered in a restricted distribution program at certified healthcare facility with careful monitoring. Plus, the therapy is delivered via continuous IV infusion over two and a half days, meaning treatment is reserved for the most severe cases.
“It's enabled us to really understand the treatment or the referral patterns in the PPD marketplace itself and establish strong working relationships with patient advocacy groups as well,” Benecchi said of Zulresso. The company has also worked with payers, which will help with zuranolone's launch.
Greene said OB-GYNs and pediatricians are most often the physicians who detect PPD in mothers, but treatment can take a long time and is typically outside the time frame of when a patient would be within that care. Treatment can also sometimes mean a referral to psychiatric care, which can take a very long time.
“If it takes months to get well, that's not in the time frame that they’re treating that mom and that baby,” Greene said. “Something like zuranolone in two weeks actually fits that timeline, so we do believe that we'll have prescribers for mom in areas outside psych.”
He continued, “When mom's unwell and can't attach to the baby, that's bad for the mom, the baby and [has a] generational impact.”
Sage is still waiting to hear whether zuranolone will get a priority review from the FDA, which could shave four months off the decision timeline. But Greene said the unmet need is very clear, and he hopes the agency will act swiftly. However, he acknowledged that the FDA is currently understaffed, so should the agency opt for a standard review, he suspects it could simply be a matter of resources rather than a comment on zuranolone’s ability to address an unmet need.
The FDA has not yet indicated whether an advisory committee meeting is needed; however, Chief Development Officer Jim Doherty, Ph.D., said the company is ready either way.
“We would see this as a great opportunity to present the entire story of zuranolone, and we will plan to be ready if is decided,” Doherty said.