Tonix获得FDA批准纤维肌痛药物Tonmya

2025-08-16 04:31

The U.S. FDA has granted approval to Tonix Pharmaceuticals' (NASDAQ:TNXP) Tonmya (cyclobenzaprine sublingual tablets) for fibromyalgia.
The company said that Tonmya is the first new treatment for the condition in more than 15 years.
It is to be taken at bedtime. As a sublingual therapy, it is rapidly absorbed into the bloodstream.
Approval was based on efficacy results of around 1,000 patients in two phase 3 double-blind, placebo-controlled trials.
In March, shares jumped after the company announced the FDA wouldn't require an advisory committee meeting for the then candidate.
Tonmya should be available starting in Q4.
After closing down ~14% Friday, the stock is up ~19% in after-hours trading.

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