When Tonix came to us, the stakes were high, and the timelines were tight. Their goal? To submit a New Drug Application (NDA) for TONMYA™ and, for the first time in over 15 years, bring a new Food and Drug Administration (FDA)-approved treatment for fibromyalgia to market. For patients living with chronic pain and non-restorative sleep, the therapy represented hope.
But submitting an NDA to the FDA is never simple. From non-clinical and clinical studies, through regulatory interactions at agency meetings and safety and efficacy data integration, to drafting prescribing information and more—it’s a complex process. FDA is evaluating both the science presented and the story behind the program.
For Tonix, TONMYA™ was the culmination of more than a decade of research. Multiple well-controlled studies. Millions of data points. Countless hours of analysis. In an NDA, every dataset, document, and response to information requests (IRs) must stand up to the scrutiny of regulatory feedback. Precision and efficiency matter. Tonix needed a CRO partner with integrated expertise who could work quickly without sacrificing scientific rigor, and navigate complexity with ease.
Why NDAs Push Sponsors to the Limit
Working on an NDA is more than paperwork. It requires coordinating many moving parts when the pressure is on. Rho’s NDA support strategy in this case included:
- Early collaboration with Tonix on key messaging, risk-benefit profile, and label claims with Rho’s team of regulatory subject matter experts
- Pre-NDA meeting support to align with FDA on the plans for NDA submission and strategic planning for NDA development to advance timelines with efficiency
- Rapid coordination of FDA IR responses to keep the review on track
- Full label negotiation support
There were thousands of interdependent documents and multiple vendors feeding data into a single submission. The sponsor had to make sure each piece was aligned to avoid holdups and derailed timelines—while under the pressure of being the first new-to-market fibromyalgia drug in almost two decades.
With a breakthrough like that on the line, we knew it would take more than just our experience. It would take a team working in sync to turn science into impact.
A True Extension of Your Team
What carried this program forward was not only technical expertise, but also the Cohesion Effect in action. From the start, Rho didn’t just act as another CRO. We became an extension of Tonix’s team, standing shoulder-to-shoulder with them because we took their success seriously. That meant anticipating needs before they became bottlenecks, adapting when there were roadblocks, and staying unified when demands peaked.
Every action was intentional. With Rho’s end-in-mind mindset, we helped Tonix prepare their dossier with an eye for messaging and FDA expectations from the start, identifying potential topics that could come up during review along the way. When issues came up, we not only flagged them, but worked with Tonix to solve them to keep timelines on track. When the FDA sent IRs, our rapid response team mobilized quickly to provide accurate, consistent responses. And when the label negotiations came down to the wire, we worked side by side with Tonix to secure agreement without losing momentum.
What Symbiosis Looks Like in Action
Behind an NDA is a team of people, including regulatory specialists, biostatisticians, non-clinical experts, and many others who work as one. There are long hours, honest conversations, and moments where plans change at a moment’s notice. What made the difference here wasn’t the process, but the trust. Tonix knew we had their back, while we knew what was at stake for them—along with the patients anticipating TONMYA™.
That’s what symbiosis looks like, and it’s what sponsors need in a CRO. It’s not transactional. It’s relational. And it’s the kind of partnership that turns pressure into progress and complexity into clarity, leading to regulatory approval.
The Right CRO Changes Everything
Facing an NDA doesn’t have to be daunting. With the right partner—one that isn’t siloed, who understands the current regulatory environment, who provides full support, and who loves science just like you—good things happen. The story of the TONMYA™ approval is proof of this. At Rho, we don’t just manage submissions. We move programs forward with precision, adaptability, and a commitment to shared success. That’s what makes us different.
