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