FDA Accepts NDA for TNX-102 SL, Tonix Nonopioid Analgesic for Fibromyalgia

Tonix Pharmaceuticals announced today that the FDA has accepted the company's New Drug Application for TNX-102 SL (cyclobenzaprine HCl), a nonopioid, centrally acting analgesic for treatment of fibromyalgia pain.

The 5.6 mg sublingual tablet developed for bedtime dosing and for chronic use was granted Fast Track designation by the FDA in July. According to the Tonix announcement, the FDA will assign a Prescription Drug User Fee Act (PDUFA)
target action date in a Day 74 Letter that will also include the planned review timeline and preliminary information on the potential for an advisory committee meeting.

If approved, TNX-102 SL would be the first in a novel class of analgesics for treating fibromyalgia in more than 15 years, said Tonix.

“The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the US," Seth Lederman, MD, Tonix chief executive officer, said in the news release. “The fibromyalgia community...has been waiting for a new drug for over 15 years."

An insurance claims analysis, commissioned by Tonix, revealed that 18 months after a diagnosis of fibromyalgia, individuals were more likely to be prescribed opioids than all 3 drugs now approved by the FDA for the condition combined. Lederman added. Patients and physicians alike widely report dissatisfaction with currently available treatments, the company stated.

TNX-102 SL targets the nonrestorative sleep component of fibromyalgia through potent binding and antagonism at 4 postsynaptic nueuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. The active ingredient in TNX-102 SL, cyclobenzaprine, is not associated with either addiction or physical dependence, according to the Tonix statement.

Positive safety and efficacy data from two 14-week randomized, double-blind placebo-controlled phase 3 clinical trials support the NDA submission for TNX-102 SL as a treatment for fibromyalgia to be taken at bedtime. RELIEF, completed in December 2020, significantly reduced daily pain compared with placebo (P =.010), satisfying the trial's prespecified primary endpoint, Tonix reported.

RESILIENT, a confirmatory phase 3 study, was completed in December 2023 and met the same primary endpoint, significantly reducing daily pain vs placebo (P <.001). In terms of safety, TNX-102 SL was described as "well tolerated with an adverse event profile comparable to prior studies with no new safety signals observed." Excluding COVID-19, systemic adverse events in RELIEF and RESILIENT were lower than 4.0%.

Fibromyalgia, understood to be a result of central sensitization, is a common chronic pain disorder that is estimated to affect more than 10 million US adults, who are predominantly women. Brain imaging studies have localized the functional disorder to the insula and anterior cingulate cortex. The most common symptoms reported by individuals diagnosed with the condition include chronic widespread pain, nonrestorative sleep, fatigue, and cognitive dysfunction. Depression, anxiety, headache, and abdominal discomfort are also commonly described.

“We look forward to working closely with the FDA throughout the NDA
review period with the goal of bringing TNX-102 SL to the market to address the significant unmet needs of the fibromyalgia community as quickly as possible," Lederman concluded.

Source: Tonix Pharmaceuticals announces FDA acceptance of the New Drug Application (NDA) for TNX-102 SL for fibromyalgia. News release. Tonix Pharmaceuticals. December 17, 2024. Accessed December 17, 2024. https://ir.tonixpharma.com/news-events/press-releases/detail/1541/tonix-pharmaceuticals-announces-fda-acceptance-of-the-new