The USFDA recently gave a Breakthrough Therapy designation to Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP)’s TNX-102 SL, a next-gen treatment for PTSD. The biggest benefit of this designation is that the company’s product for posttraumatic stress disorder will now receive a priority review under New Drug Application (NDA). This means that the review shall now be done in 6 months, instead of 10. Also, this designation to company’s new treatment will help it in getting FDA’s real-time advise and suggestions regarding the design of this product. The FDA’s input to the company on its drug will enable it in timely and right execution of the development program.
PTSD- a serious disease
The company said that FDA’s designation to their drug, TNX-102 SL, means that the federal body understands the seriousness of PTSD. Also, the CEO and MD of company, Seth Lederman said that the decision of FDA is indicative of the fact that their drug has potential of more advantage over present PTSD therapies.
It is vital to note that Tonix Pharmaceuticals is also gearing up for Phase 3 HONOR study in the beginning of the next year. The commitment of FDA to review and provide inputs for development program of TNX-102 SL will enable the acceleration of this program.
According to the company’s statement, the fast approval of their new next-generation drug will enable it in providing better treatment to PTSD patients. There are a range of problems and conditions associated with the ailment, one of which also includes military-related PTSD condition.
Phase 3 clinical study preparations on the swing
The company had held Phase 2/Pre-Phase 3 meeting with US Food and Drug Administration on the basis of its Phase 2 AtEase study. Tonix is now gearing up for the Phase 3 study and it is also planning to enrol the patients for this trial.
The company now believes that its designation from FDA will play an important role in receiving comments on their HONOR study.
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