FDA grants its new drug TNX-102 SL for fast track treatment of Alzheimer's disease
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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Recently, the U.SPharmaceutical(Inc.) announced
that the U.SFood andDrug(
FDA
has granted it a fast-track designation for theof
new drugs (SL) for the treatment of Alzheimer's disordersTNX-102 SL (trade name Tomya) used to treat post-traumatic stress disorder (PTSD) has previously been designated as a breakthrough therapy by the FDAThe drug for the treatment of military-related post-traumatic stress disorder is currently in the clinical phase 3 study phase, and a mid-termanalysisis expected in the third quarter of 2018Tonix's TNX-102 SL 5.6 mg ClinicalTrial (IND) was approved by the FDA in April this year, and the trial could be used to support The TNX-102 SL For Phase 2 critical efficacy studies in the treatment of patients with Alzheimer's disease In addition to assessing the safety and efficacy of TNX-102 SL bedtime therapy for 8 weeks, the Phase 2 clinical study will analyze genomic DNA to identify biomarkers that may be associated with therapeutic responses TNX-102 SL is a new research drug containing stymied cyclenicine, which has not yet been approved for any indications TNX-102 SL had previously been used in fibromyalgia treatment trials, but Phase III clinical safety and efficacy data did not reach the main end of the study
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