Tonix Pharmaceuticals is planning to expand the use of its investigational therapy TNX-102 SL, which is currently being explored as therapy for post-traumatic stress disorder (PTSD), for the treatment of people with fibromyalgia.
The company is going to launch a Phase 3 clinical trial during which researchers will assess the safety and efficacy of 5.6 mg of TNX-102 SL (also known as Tonmya) in fibromyalgia patients.
TNX-102 SL is a reformulation of the muscle relaxant compound cyclobenzaprine that was reinvented in the form of sublingual (under the tongue) tablets with analgesic properties.
“We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD,” Seth Lederman, MD, president and CEO of Tonix, said in a news release. “We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation.”
The therapeutic potential of TNX-102 SL has been previously studied in Phase 2 (BESTFIT, NCT01903265) and Phase 3 (AFFIRM, NCT02436096) trials in patients with fibromyalgia. Results indicated the daily administration of TNX-102 SL at a 2.8 mg dosage could reduce patients’ pain, improve their sleep quality, and could also have beneficial effects on other fibromyalgia-related symptoms.
Despite the positive effects, the company decided to stop the development of TNX-102 SL as a treatment for fibromyalgia and focus on its potential for PTSD treatment.
Preliminary data of a Phase 3 trial (RECOVERY, NCT03841773) in people diagnosed with PTSD have suggested that when taken at a higher dose (2 x 2.8 mg daily), the treatment also had an analgesic effect, while retaining an acceptable safety and tolerability profile.
The new safety and efficacy data of TNX-102 SL suggest that increasing the dose from 2.8 mg to 5.6 mg in the new fibromyalgia study will likely provide the clinical evidence to support the use of this investigational therapy for the management of fibromyalgia.
Supported by these results, the company has gotten the green light from the U.S. Food and Drug Administration (FDA) to further assess the efficacy and safety of a higher dose of the investigational therapy in patients with fibromyalgia in a new Phase 3 trial.
“FDA’s acceptance of the well-established safety information of currently marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring,” Lederman said.
“We have extensive clinical experience and data collected over the past seven years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we are very pleased with the FDA’s clear guidance and support to help advance our lead product candidate, TNX-102 SL, in fibromyalgia and PTSD toward [new drug application] approvals,” he said.
Registration of TNX-102 SL 5.6 mg for the fibromyalgia indication is expected to be supported by two positive Phase 3 studies, and long-term safety exposure data from the PTSD program may support the submission of a New Drug Application (NDA) for fibromyalgia.
“There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering that approximately one-third of fibromyalgia patients are on chronic opiates,” Lederman said. “Tonix could potentially address this need for a non-opiate, non-addictive analgesic for fibromyalgia and possibly other indications in which improvement in sleep quality can indirectly provide clinical benefit to the primary symptoms.”
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