Meet the Speaker - Errol Gould
Ahead of the summit, we spoke with Errol Gould, Senior Vice President, Medical Affairs at Tonix Medicines, to discuss the progress being made across the non-opioid pain landscape, the recent approval of TONMYA®, and the opportunities still ahead for advancing pain care.
In this interview, he reflects on the lessons learned from TONMYA's development journey, explores the role of biomarkers and patient phenotyping in improving clinical trial success, and shares his perspective on how the pain community can continue to deliver more precise, effective non-opioid treatment options for patients.
Since joining Tonix in 2024, how have you seen the non-opioid pain landscape evolve, and what changes have been most encouraging to you?
Since joining Tonix in 2024, I’ve seen the non-opioid pain field move from cautious optimism toward clinical and regulatory validation. Approvals of new non-opioid treatments have expanded options for patients and shown that progress is possible, even where drug development has historically been difficult. One example is Tonix’s TONMYA® (cyclobenzaprine HCl sublingual tablets), approved by the U.S. Food and Drug Administration (FDA) for the treatment of fibromyalgia in adults. It is the first new FDA-approved treatment for fibromyalgia in more than 15 years.
I am most encouraged by the growing recognition that pain is not one disease with one solution. We are seeing greater attention to distinct mechanisms, better patient characterization, and treatments designed around the biology and lived experience of specific pain conditions. The increased focus on trial quality, including patient-reported outcomes, accurate symptom reporting, and strategies to reduce variability, can also help us identify treatments that provide meaningful benefits to patients.
Congratulations on the TONMYA approval! Looking back on the journey to this milestone, what does this achievement mean to you personally, and what were some of the key factors that made it possible?
Although I joined Tonix during the later stages of TONMYA’s clinical development, it has been deeply meaningful to see it progress to FDA approval and commercial availability for patients with fibromyalgia. This achievement reinforces why we do this work: behind every dataset are people living with chronic pain who need additional treatment options.
Several factors made this milestone possible: a strong scientific rationale, a differentiated sublingual formulation designed for bedtime administration, rigorous clinical evaluation, and the persistence to learn from each study. The commitment of participants, investigators, clinical sites, and teams across Tonix was equally important. For me, the approval demonstrates what sustained scientific discipline, careful execution, and a clear focus on patients’ needs can accomplish.
TONMYA represents an important milestone for the pain community. What lessons from its development do you believe could help accelerate the next generation of non-opioid pain therapeutics?
One important lesson is that innovation is not limited to discovering an entirely new molecule. It can also come from rethinking formulation, route of administration, timing of treatment, and how a therapy addresses the biology of a condition.
A second lesson is the importance of persistence combined with a willingness to learn. Pain trials are vulnerable to patient heterogeneity, variability in symptom reporting, placebo responses, and differences in study execution. We need to examine unexpected results objectively and use those insights to strengthen subsequent studies.
Finally, trial quality matters at every level. Selecting appropriate patients and endpoints, training sites, educating participants without inflating expectations, and collecting reliable patient-reported data can all influence whether a trial accurately measures a treatment’s effect. Applying these lessons early can help future programs make better decisions and progress more efficiently.
With increasing investment, regulatory momentum, and clinical progress across the sector, what scientific or therapeutic advances are you most excited about today, both within Tonix and across the wider pain field?
Within Tonix, I am excited about what we can learn from TONMYA’s use in clinical practice among patients with fibromyalgia. Understanding patient experiences, treatment patterns, and outcomes can help us identify remaining gaps in care. Beyond fibromyalgia, we are also studying TNX-102 SL, the development designation for the formulation marketed as TONMYA, in major depressive disorder and acute stress disorder/acute stress reaction. These uses remain investigational and are not FDA-approved.
Across the wider pain field, I am encouraged by the range of approaches being investigated, including peripherally acting sodium-channel therapies, centrally acting treatments, biologics, novel receptor targets, and therapies designed for more clearly defined patient populations. I am particularly interested in biomarkers, sensory phenotyping, digital measures, and other tools that may help us better match treatments to patients.
More diverse therapeutic approaches and better clinical development tools could help us move toward more precise pain management and reduce reliance on trial-and-error treatment.
Despite the progress we've seen, what do you believe remain the greatest challenges to developing and delivering effective non-opioid pain treatments to patients?
One of the greatest challenges is the complexity and heterogeneity of pain. Two patients with the same diagnosis may have very different underlying mechanisms, symptoms, comorbidities, and responses to treatment.
Another challenge begins before a potential therapy reaches clinical testing. Animal models cannot fully reproduce all human pain conditions, particularly complex chronic disorders shaped by sleep, mood, cognition, and the broader patient experience. Even when a model captures one component of a condition, it may not reliably predict clinical efficacy. This translational gap makes target validation and candidate selection difficult and highlights the need for complementary human-based models, biomarkers, and early proof-of-mechanism studies.
Clinical trials also present significant challenges. Pain is subjective, and reported pain can be influenced by expectations, previous treatment experiences, and the trial environment. Variability in reporting and high placebo responses can make it difficult to distinguish a treatment effect from placebo. Better patient phenotyping, participant education, site training, and outcome measurement can help address these challenges.
Finally, FDA approval must be followed by access for appropriate patients. That requires clinician education, patient awareness, market access, affordability, and evidence of meaningful value in clinical practice. Scientific innovation and effective implementation need to advance together.
Finally, what are you most looking forward to discussing with your peers at the 2nd Non-Opioid Pain Therapeutics Summit?
I’m most looking forward to candid discussions about what is working in non-opioid pain development and where we can improve. We learn from successful programs, but trials with unexpected or inconclusive results can be equally instructive.
I am particularly interested in exchanging ideas about participant education, expectation management, accurate pain reporting, patient selection, and methods for improving a trial’s ability to detect a treatment effect. I’d also like to hear how others are applying biomarkers, patient-reported outcomes, and emerging technologies to strengthen clinical development.
Ultimately, I look forward to connecting with peers who share the goal of translating strong science into treatments that make a meaningful difference for people living with pain. This meeting gives us an opportunity to compare experiences, challenge assumptions, and identify practical approaches that can help the field progress.