Anticipating TNX-102 SL's Addition to the Fibromyalgia Toolkit, with Andrew Sharobeem, DO

The Food and Drug Administration (FDA) decision on Tonix Pharmaceuticals' biologics license application for TNX-102 SL is looming, with an announcement expected today, August 15, for what may be the first approved drug for treating fibromyalgia in over 15 years.

In anticipation of the decision, HCPLive caught up with Andrew Sharobeem, DO, a rheumatologist at Arizona Arthritis & Rheumatology Associates, to learn more about his thoughts on TNX-102 SL and how it might fit into the treatment toolkit for fibromyalgia.

Sharobeem shared that while it may be a useful pain management strategy to add to the treatment landscape of fibromyalgia, it's not something that he thinks will revolutionize fibromyalgia care. Rather, he is looking forward to other treatment strategies for fibromyalgia including transcranial magnetic brain stimulation and vagus nerve stimulation. One benefit of TNX-102 SL he pointed out is that it would be the potential first member of a new class of non-opioid analgesic drugs for fibromyalgia and thus represents a safer option to control pain than opioids.

"It's helpful to have something like [TNX-102 SL] to navigate around certain medications that we know are not going to be great and are going to cause way more side effects than they do benefits [like opioids]. But it's not necessarily that big splash that I'm looking forward to," Sharobeem said.

TNX-102 SL is a sublingual formulation of cyclobenzaprine. Recent phase 3 data from the RESILIENT study were presented in a poster at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 in Barcelona, Spain, taking place June 11-14, 2025. Investigators found that TNX-102 SL demonstrated a highly statistically significant improvement in the primary endpoint of statistically significantly reducing daily NRS pain scores compared with placebo starting at week 1 and continuing until Week 14 (P <.0001), with an effect size of 0.38. Key secondary endpoints were also met, these were Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance, PROMIS fatigue, and diary sleep quality ratings, which were all found to be statistically significant (all P <.001) compared to placebo, with effect sizes ranging from 0.32–0.50.

TNX-102 SL was well-tolerated, with 81.0% of patients on TNX-102 SL and 79.2% on placebo completing the study, with treatment-emergent adverse events (AEs) leading to discontinuation in 6.1% and 3.6%, respectively. Serious AEs occurred in 2 patients (0.9%) on TNX-102 SL and 3 patients on placebo.

Sharobeem has no relevant disclosures to report.

REFERENCE

Iglehart III I, Sullivan G, Lederman S. Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (Tnx-102 SL) Targets Nonrestorative Sleep and Provides Sustained Pain Reduction.