Shares of Tonix (TNXP, Financials) climbed as much as 31% to an intraday high of $18.44 as of Thursday, following the company's announcement of positive Phase 3 clinical trial results for TNX-102 SL, an investigational non-opioid treatment for fibromyalgia.
Tonix stock, on last look, is up 24.4% to $13.57 as of 12:58 p.m. GMT-5 on Thursday.
Two double-blind, placebo-controlled investigations showed that the medication statistically significantly reduced fibromyalgia-related pain. Tonix reported the results at Vienna, Austria's 7th International Congress on Controversies in Fibromyalgia. For a determination on marketing clearance, the U.S. Food and Drug Administration has set an Aug. 15 Prescription Drug User Fee Act target date.
If approved, TNX-102 SL would be the first novel fibromyalgia medication in more than 15 years as well as the first in a new non-opioid analgesic class, according to the company. Designed for nighttime use, the sublingual formulation addresses non-restoring sleep, which is connected to pain connected to fibromyalgia.
The drug's avoidance of first-pass metabolism, according to Tonix's Chief Executive Officer Seth Lederman, results in reduced levels of norcyclobenzaprine, an active metabolite accumulated with oral cyclobenzaprine usage. Though there is no data proving their long-term efficacy, he pointed out that many fibromyalgia sufferers are administered opioids.
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