Tonix Pharmaceuticals reported late Friday that the Food and Drug Administration had approved its Tonmya treatment for fibromyalgia. Fibromyalgia, a condition affecting 10 million adults in the U.S., mainly women, causes chronic pain and fatigue. Tonix shares opened down 14% following the FDA news and a Monday morning press conference.
The once-a-day, under-the-tongue tablet will be commercially available in the fourth quarter. Tonix said that Tonmya is the first new FDA-approved fibromyalgia treatment in over 15 years. TNXP stock had traded 17% higher following the FDA news on Friday.
FDA Approves Fibromyalgia Advance
The Chatham, N.J., company began a conference call at 8:30 a.m. ET to discuss its outlook. CEO Seth Lederman said that approval of Tonmya "represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this conditions causes."
Tonix said that two Phase 3 clinical trials showed that Tonmya "significantly reduced daily pain scores compared to placebo" and was generally well tolerated.
The Tonix news release included a quote from Andrea Chadwick, a University of Kansas Health System specialist in anesthesiology, pain and perioperative medicine. Current treatments "that are processed through the liver can result in metabolites that could affect a medicine's efficacy and safety over time." By contrast, she said, "Tonmya is administered sublingually, which is designed to reduce pain quickly and durably with a tolerable safety profile."
Tonix said the most common adverse effects included numbness in the mouth, oral discomfort, abnormal product taste, drowsiness, tingling, pricking or burning in the mouth, oral pain, fatigue, dry mouth, and canker sore.
TNXP Stock Volatile
Tonic Pharmaceuticals stock slumped 22%, trading around 40 on Monday afternoon.
Tonic carried out a 1-for-100 reverse stock split on Feb. 5 to satisfy the Nasdaq's minimum $1 bid price for continued listing. Shares closed at 14.98 on Feb. 5, but had been on a roll lately.
Shares traded as high as 69.97 last week. TNXP has an very high 21-day average true range of 12.08% A stock's 21-day ATR, a metric available on IBD's MarketSurge, reflects its daily volatility. Higher numbers raise the risk of a shakeout that can trigger sell rules. Current market conditions are conducive for buying stocks with pretty high ATRs of up to 8%.
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