Tonix Pharmaceuticals Inc. (NASDAQ: TNXP) stock gained by 5.65% at the last close while the TNXP stock price rises by 3.82% in the pre-market trading session. Tonix is a clinical-stage pharmaceutical business dedicated on finding, licensing, purchasing, and developing small molecules and biologics to cure, prevent, and relieve human illness. Tonix’s portfolio is mostly made up of pharmaceutical candidates for the central nervous system (CNS) and immunology.
What is happening?
Tonix Pharmaceuticals has recently revealed the previously published data from its Phase 3 RELIEF study testing the TNX-102 SL tablet for the treatment of fibromyalgia.
Fibromyalgia is a condition that causes extensive musculoskeletal pain, as well as tiredness, sleep, cognitive, and mood problems. The findings were presented at the 2021 Annual Meeting of the American Society of Clinical Psychopharmacology. The trial’s primary goal was fulfilled with TNX-102 SL, which considerably reduced daily discomfort when compared to placebo. In fibromyalgia patients, it was linked to a greater proportion of more than 30% pain responders compared to placebo.
At 5.6 mg, TNX-102 SL exhibited action in critical secondary endpoints such as sleep quality, fatigue reduction, and fibromyalgia-specific functional recovery. TNX-102 SL was also well-tolerated, with no adverse effects like weight gain, sleeplessness, nausea, or sexual dysfunction that have been reported with other authorized oral fibromyalgia medications.
President and CEO of TNXP, Seth Lederman stated:
In previous fibromyalgia trials, the sublingual formulation of TNX-102 SL for transmucosal absorption showed promise at the 2.8 mg dosage, but TNXP feels that RELIEF shows that 5.6 mg is the optimal dosage for this patient population.
RALLY, a second pivotal Phase 3 study being conducted by TNXP, is projected to have intermediate data in the third quarter of 2021 and topline data in the first quarter of 2022.