By Ed Coghlan
Some bad news for the millions of fibromyalgia patients hoping there might an answer to getting more restorative sleep.
Tonix Pharmaceuticals is going to discontinue the study of its TNX-102 SL, which held—and may still hold—great promise for addressing the fibromyalgia sleep issue.
The data did not achieve statistical significance in the primary efficacy endpoint: the proportion of patients who reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis. However, TNX-102 SL did show statistically significant effects on pain when analyzed by other standard statistical approaches. TNX-102 SL activity in fibromyalgia was cross-validated by two additional endpoints, Patient Global Impression of Change and Fibromyalgia Impact Questionnaire-Revised. These endpoints assess global improvement and a range of fibromyalgia symptoms and function. TNX-102 SL showed strong effects on improving sleep quality by the daily diary and the PROMIS sleep disturbance scale. The internal consistency of these results provides clear evidence of beneficial effect of TNX-102 SL for the treatment of fibromyalgia.
In any FDA trial, follow-up with patients is critical in order to assess efficacy. And follow-up became a challenge in this study.
An unexpected imbalance in patient discontinuations for reasons unrelated to efficacy or tolerability (for example, a patient relocating away from the clinical site. It created a negative bias in the primary responder analysis because any patient who left the study, for any reason prior to completion, was labeled a non-responder despite their results up to that point.
“TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the AFFIRM study. Despite achieving clinically meaningful results from AFFIRM, we have greater clarity on the regulatory path forward in our PTSD program. We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD program to Phase 3,” said Seth Lederman, M.D., Tonix president and chief executive officer.