The FDA Tuesday approved Sage’s Zulresso after a three-month REMS-related delay.
Sage Therapeutics has the first-ever approval for a prescription drug for postpartum depression, thanks to the FDA’s Tuesday nod for Zulresso. But it also has a number of big challenges ahead.
Regulators greenlighted the product—a one-time injection—after a three-month delay, which they took to give themselves some extra time to work on a risk evaluation and mitigation strategies (REMS) program.
But while REMS can often get in the way of uptake, Sage’s executives don’t think it’ll be a hurdle. “We can make it feasible for physicians and patients … to participate in the REMS,” chief business officer Mike Cloonan said, adding that “we’re confident in our ability to execute against” the safety-ensuring program.
One aspect of Zulresso’s launch that could prove tricky, though? Working out just how centers that administer the drug can provide a positive patient experience during Zulresso’s lengthy 60-hour IV infusion period. Logistics will vary center by center and hospital by hospital, Cloonan said, and moms may have to separate from their babies for a period of time.
To Sage, what’s important is that “the mom feels secure in how she’s going to be cared for in that period of time,” Cloonan said. By contrast, “what we don’t want” is patients isolated on psychiatric floors, which “exacerbates the stigma” surrounding PPD and “makes it more difficult.”
Finding administration centers that will follow the REMS certification process and focus on patient experience isn’t enough, however. Sage also needs its centers to have what it calls a “provider champion”—someone who’s going to advocate for the product and for PPD treatment itself, Cloonan explained—as well as appropriate framework for reimbursement. And now that the drug is approved, “we’ll be able to accelerate” the process of identifying centers that check all of Sage’s boxes, Cloonan said.
The company will have 55 key account managers on the job, and the rest of its 180-person sales force will be calling on OB-GYNs and psychologists to help them understand Zulresso so they can direct patients to Sage’s centers. But those detailing the product will have their own challenges to face as they work to build awareness in a brand-new market.
Of course, Sage has already started laying the groundwork; an existing campaign directed at healthcare professionals called “Leave no mom behind,” encourages doctors to “know PPD,” and a dedicated website provides them with screening info, care guidance and patient materials. A separate website for patients, “See PPD,” lays out facts and symptoms of the condition and directs patients on how to navigate the stigma around the condition to talk with their doctors.
The burden of stigma “absolutely affects women with PPD,” Cloonan said, noting that many of the 400,000 women in the U.S. who suffer from the condition “fall through the cracks and don’t get treated.”
“We hope Zulresso will bring them out of the silence—bring them forward and get them the treatment that they need,” he said.
There’s another group Sage has been working to educate about PPD too, and that’s payers. The company has already “engaged significantly” with payers to help them understand PPD. “That’s been a big part of our prelaunch strategy and it will continue to be in the postlaunch setting,” Cloonan said.