FDA decision on TNX-102 SL for fibromyalgia awaited; potential first new non-opioid treatment in 15 years
The FDA decision on Tonix Pharmaceuticals’ sublingual cyclobenzaprine formulation, TNX-102 SL, is expected today, August 15, as regulators weigh whether it could become the first approved drug to treat fibromyalgia in more than 15 years.
In preview, rheumatologist Andrew Sharobeem, DO, of Arizona Arthritis & Rheumatology Associates, shared his take on where TNX-102 SL might fit into fibromyalgia care. He views it as a potentially useful addition to the treatment toolkit, but not a revolution in how fibromyalgia is managed. He said he is hopeful about other emerging approaches, including transcranial magnetic stimulation and vagus nerve stimulation, which he believes could broaden options for patients. A key advantage of TNX-102 SL, he noted, is that it would represent the first member of a new class of non-opioid analgesics for fibromyalgia, offering a safer alternative to opioids for pain control.
“It’s helpful to have something like [TNX-102 SL] to navigate around medications we know aren’t great and tend to cause more side effects than benefits [like opioids]. But it’s not necessarily the big breakthrough I’m hoping for,” Sharobeem said.
TNX-102 SL is a sublingual form of cyclobenzaprine. Phase 3 data from the RESILIENT study were presented as a poster at the EULAR Congress 2025 in Barcelona, Spain, in mid-June. The investigators reported a highly statistically significant improvement in the primary endpoint: a reduction in daily NRS pain scores versus placebo beginning at Week 1 and persisting through Week 14 (P < 0.0001), with an effect size of 0.38. Secondary endpoints also showed meaningful gains: improvements in PROMIS sleep disturbance, PROMIS fatigue, and diary sleep quality ratings, all statistically significant (P < 0.001) with effect sizes ranging from 0.32 to 0.50. Safety data were favorable for a phase 3 trial. Completion rates were 81.0% for TNX-102 SL versus 79.2% for placebo. Treatment-emergent adverse events leading to discontinuation occurred in 6.1% of TNX-102 SL participants compared with 3.6% on placebo. Serious adverse events occurred in 0.9% of the TNX-102 SL group (2 patients) versus 3 patients in the placebo group. Sharobeem disclosed no relevant conflicts. If approved, TNX-102 SL would mark the advent of a non-opioid analgesic option specifically for fibromyalgia and could help reduce reliance on opioids for pain management. While not expected to replace existing therapies overnight, the drug may pave the way for broader exploration of non-opioid strategies to improve sleep, fatigue, and overall pain control in fibromyalgia patients, potentially complementing neuromodulation approaches as part of a multi-modal treatment plan. What this means for patients and clinicians - New non-opioid option: TNX-102 SL could provide a safer alternative to opioids for managing fibromyalgia pain. - Sleep and fatigue benefits: Early signals show improvements in sleep quality and fatigue, which are major concerns for many patients. - Complementary approach: The drug is likely to be one component of a broader treatment strategy that includes behavioral and neuromodulation therapies. - Monitoring needed: As with any new therapy, real-world safety and long-term effects will be important to monitor post-approval. Summary: The anticipated FDA decision on TNX-102 SL follows encouraging phase 3 results showing meaningful pain relief and sleep benefits, with a favorable safety profile. If approved, the therapy would introduce a first-in-class non-opioid option for fibromyalgia and could influence future research and treatment strategies, while remaining one piece of a broader, multi-modal care approach. Positive, measured optimism surrounds its potential to expand the fibromyalgia treatment landscape.