The U.S. Food and Drug Administration (FDA) recently announced that it has approved TPOXX as the first treatment for smallpox. The research report was published in the New England Journal of Medicine and the journal Antimicrobial Agents and Chemotherapy.
TPOXX will help in addressing an important need of patients with smallpox. Reportedly, the majority of the world’s population is not protected against this infectious disease. It killed about 30% of the infected people.
SIGA Technologies has developed TPOXX. The company had submitted a New Drug Application (NDA) for TPOXX to the FDA in December 2017. This application was presented to the FDA as the human studies did not notice any major side effects of this medicine. Also, its impact in non-human primates and rabbits proved the efficacy of the medicine to treat the infections same as that of human smallpox. However, the effectiveness of the drug on the humans is not completely clear.
On a related note, Tonix Pharmaceuticals recently announced that the U.S. FDA has approved a fast track designation to TNX-102 SL. It is the latest investigational drug of the company that will be useful in the treatment of agitation in Alzheimer’s disease.
Previously, the drug TNX-102 SL was also intended for the treatment of posttraumatic stress disorder (PTSD) as a Breakthrough Therapy. Currently, this drug is in the Phase-3 study for military-related PTSD. An interim analysis of the drug is expected to come out in the third quarter of 2018.
Seth Lederman, M.D., Chief Executive Officer of Tonix, proclaimed that the fast track designation by the FDA indicates that TNX-102 SL has the capability to address the major medical needs for a serious condition. He further stated that there are no FDA-approved treatments for agitation in Alzheimer’s disease at present in spite of a need for an effective therapy.