The pharmaceutical industry has a habit of dressing up old drugs in new clothes and calling it innovation. The latest example? An application by Otsuka and Lundbeck Pharmaceutical to approve Rexulti (brexpiprazole) and Zoloft (sertraline) as a so-called first “new treatment” for PTSD in decades. But behind the headlines, press release buzzwords, and corporate optimism lies a deeply flawed drug application—one that fails patients, distorts data, and puts commercial gain ahead of public health.
Articles in advance of July’s FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) meeting have some touting this combination treatment as “First New PTSD Drug in Two Decades on the Horizon?” But if you look beneath the surface, you’ll see something very different.
What’s being sold here isn’t a breakthrough. It’s a brand extension. A marketing strategy dressed up in scientific language. And the patients who stand to lose the most are veterans, trauma survivors, and people who’ve already been let down by the system.
You can view the full FDA briefing materials and meeting agenda here:
A Note Before the Data
This was my first drug review I weighed in on as a member of the public—not as a sitting member of the FDA’s advisory committee. My third consecutive term as Consumer Representative on the Psychopharmacologic Drugs Advisory Committee ended just a few months ago.
When I reviewed the roster for this advisory committee meeting, I noticed that my former position is currently vacant. And while the FDA has, in the past, temporarily reappointed vetted former members when needed, that didn’t happen here.
I’m not raising this to dwell on the decision, but to highlight something important: who is—and isn’t—in the room can shape the conversation. The absence of a designated, independent consumer voice at this meeting is worth noting.
I’ve spent years inside these meetings—asking hard questions, reviewing dense regulatory documents, and working to ensure the public’s perspective was not only present, but heard.
While I may be on the outside—I’m still speaking up. Because what’s on the table isn’t just a drug application—it’s a decision with real consequences for real people. It deserves public scrutiny and a lens grounded in lived experience, not just clinical data.
I was given four-minutes to voice my concerns during the Open Public Hearing portion of the meeting.
Kim Witczak - Public Speaker #7 (Timestamp 5:28:35-5:33:08)
The Data Doesn’t Hold
The FDA asked a fundamental question in its briefing documents: “Does the data being presented support efficacy?”
The answer? Not really.
There were two pivotal Phase 3 trials. Study 071 showed a modest benefit: about a 5.6-point improvement on the CAPS-5 PTSD symptom scale. But Study 072—equally designed and powered—failed to show any benefit at all.When one of two key trials fails, that should stop the process in its tracks.
To compensate, the drug sponsors leaned on Study 061, an exploratory proof-of-concept trial that was never designed to demonstrate efficacy. Worse, the statistical plan was submitted after the trial ended. They abandoned their pre-specified testing order and applied three different post-hoc correction methods to try to make something—anything—look significant.
Even the FDA’s own statisticians flagged this: the study “raises concerns about inflation of the overall Type I error rate.” In plain English? The chances of a false positive—of a benefit that isn’t really there—were high.
And yet, here we are, talking about approval.
These Were Not Real-World Patients
One of the most shocking things buried in the FDA’s documents is the long list of exclusion criteria. These trials excluded people with suicidality, comorbid anxiety, substance use, or chronic health conditions—in other words, the very people most likely to be living with PTSD.
As someone who works with veterans and families impacted by trauma, I can tell you this is not how PTSD presents in the real world. These trials were designed to produce a clean data signal, not to reflect the complexities of actual patients. So even if you believe the results, they don’t tell us whether this drug combo will work—or be safe—for the people it’s being marketed to.
Double the Drug, Double the Risk 💊 💊
Let’s talk about the treatment itself. This proposal is not for a new drug—it’s for the concurrent initiation of two existing ones: Rexulti, a second-generation antipsychotic, and Zoloft (sertraline), an SSRI already approved for PTSD.
But this combo isn’t benign. Here’s what we know:
Rexulti is linked to akathisia (a restless agitation that can lead to self-harm), weight gain, sedation, prolactin elevation, impulse control issues, and withdrawal symptoms.
Zoloft carries a black box warning for suicidality, causes withdrawal effects of its own, and can blunt emotions—something already problematic for trauma survivors.
The trials lasted only 12 weeks, but PTSD is a lifelong condition. There is no data on:
Long-term use
Polypharmacy interactions
Discontinuation risks
How these drugs impact trauma-affected brains over time
And yet the plan is to start both drugs at once, from day one.
We’ve been here before—approve a treatment based on short-term data, then discover long-term harms too late. That is not science. That’s gambling.
The Business Model Behind the Science
Here’s the part that doesn’t get talked about enough: Zoloft is already FDA-approved for PTSD—and it’s generic.
This application isn’t about helping patients. It’s about getting a new indication for Rexulti, a high-cost, patent-protected drug.
With a PTSD approval:
The company gets additional 3 years of exclusivity.
They can promote Rexulti for PTSD to clinicians, insurers, and VA systems.
They gain leverage in formularies—potentially pushing more trauma patients into polypharmacy from day one.
It’s not just about PTSD either. Once this indication is secured, it opens the door to off-label use for trauma-related anxiety, adolescents, veterans, first responders—anyone whose suffering can be bundled under “unmet need.”
This isn’t innovation. It’s exploitation. It’s the monetization of trauma.
We Must Do Better for Veterans and Survivors
I’ve worked with veterans groups, military families, and survivors of psychiatric harm. I’ve seen firsthand how polypharmacy and poorly tested medications can derail lives. These communities don’t need another “me-too” treatment with a clever label and cleverer sales strategy.
They need trustworthy data, real support, and treatments that don’t leave them worse than where they started.
The FDA was created to protect public health, not to rubber-stamp marketing plans. If this combination eventually gets approved—despite a failed trial, a flawed proof-of-concept, and a sanitized patient population—we’re sending a message: that the appearance of innovation matters more than its reality.
Ad Com Vote + Final Thoughts
I was happy to see that the FDA Advisory Committee voted 10-1 against recommending approval of the Rexulti/Zoloft combination for PTSD, citing insufficient evidence of efficacy.
This was the right call—not because people with PTSD don’t deserve help, but because they deserve better help than this.
We don’t need another branded combo that overpromises and under delivers. What we need is accountability, solid evidence, and a shift in how we approach psychiatric drugs—not as silver bullets, but as tools that must be rigorously tested, wisely prescribed, and responsibly withdrawn.
Let’s stop mistaking marketing momentum for medical progress. This vote is a chance to draw a line in the sand.
Time will tell if the FDA follows the committee’s lead. While they usually do, there have been moments when they’ve gone the other way.
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