Tonix Pharmaceuticals Completes Food Effect, Dosing Study of TNX-102 SL, Plans New Drug Application

Tonix Pharmaceuticals Completes Food Effect, Dosing Study of TNX-102 SL, Plans New Drug Application

Tonix Pharmaceuticals has finished the essential fed-fasting and dose proportionality tests of its TNX-102 SL investigational therapy in healthy volunteers.

The data from these tests are expected to support a New Drug Application (NDA) of TNX-102 SL for the treatment of fibromyalgia (FM) and post traumatic stress disorder (PTSD), the company said in a press release.

Tonix is currently recruiting patients for a Phase 3 trial, called RELIEF, testing the therapy in people with fibromyalgia (NCT04172831). Enrollment and U.S. test site information is available here.

TNX-102 SL is a non-opioid, non-addictive analgesic, or pain killer, that acts on the central nervous system to reduce symptoms of pain. Currently, the investigational therapy has not been approved for any indication.

Developed as a reformulation of the muscle relaxant cyclobenzaprine, TNX-102 SL is administered via sublingual (under-the-tongue) delivery.

It is Tonix’s lead product candidate and is currently in Phase 3 development as a bedtime treatment for PTSD and fibromyalgia.

The preliminary results of the Phase 1 fed-fasting study (NCT04164719) indicated that there were no significant effects of a fatty meal on the rate or extent of absorption of 5.6 mg of TNX-102 SL, administered as two, 2.8 mg, sublingual tablets.

According to the company, the lack of an effect of food is consistent with transmucosal absorption — when the drug diffuses through a mucous membrane, such as under the tongue.

Oral cyclobenzaprine products have already been approved for treatment of muscle spasms, but they have been shown to be significantly affected by the absorption of food.

This can be dangerous as food effects can alter drug levels in the body, which can add unpredictability for patients with regard to therapeutic benefit or side effects.

The study also showed that the rate and extent of absorption of TNX-102 SL increases in a dose-proportional manner from 2.8 mg to 5.6 mg. The dose proportionality demonstrated in this trial validates the findings of an earlier study that used a prototype 2.4 mg formulation.

The candidate treatment also is currently in Phase 2 clinical trials for agitation in Alzheimer’s disease, and a Phase 3 study for PTSD (NCT03841773).

TNX-102 SL was previously tested in a Phase 2 BESTFIT clinical trial (NCT01903265) and Phase 3 AFFIRM clinical trial (NCT02436096) for treatment of fibromyalgia.

The results from the Phase 3 AFFIRM study, presented at the 2019 ACR/ARP Annual Meeting, show that TNX-102 SL had significant beneficial impact on sleep quality and fatigue, but did not reduce pain levels in patients with fibromyalgia.