Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as (R)-isometheptene mucate
TNX-201 · 1 trial · 1 indication
Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question). 4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; "pain-free" defined as score = 0. VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). "Pain-free" was defined as a score \<= 5
| Arm | Type | Description |
|---|---|---|
| TNX-201 | EXPERIMENTAL | 4 X 35 mg capsules to be taken when qualifying tension-type headache occurs |
| Placebo | PLACEBO_COMPARATOR | 4 X placebo capsules to be taken when qualifying tension-type headache occurs |
| Name | Type | Description |
|---|---|---|
| TNX-201 | DRUG | TNX-201 capsule |
| Placebo | DRUG | Placebo capsule |
Inclusion Criteria: 1. Capable of reading and understanding English and able to provide written informed consent to participate. 2. Male or female adults ≥ 18 and \< 65 years of age at the time of Visit 1. 3. Body mass index (BMI) ≥ 18.5 and ≤ 45.0. 4. Greater than 1 year history of episodic tensio...
TNX-201 is being developed for the treatment of tension-type headache. It is a small molecule therapeutic candidate studied in a Phase 2 clinical trial evaluating its use for a single tension-type headache episode. Tonix Pharmaceuticals is developing the drug, and it has not been approved by the FDA.
TNX-201 is being developed by Tonix Pharmaceuticals Holding Corp., which trades on the Nasdaq under the ticker symbol TNXP. The company is responsible for the clinical development of the drug candidate for tension-type headache.
TNX-201 is in Phase 2 clinical development. A completed Phase 2 trial evaluated the safety and efficacy of TNX-201 capsules for the treatment of a single tension-type headache. The drug is investigational and has not been approved by the FDA for any indication.
TNX-201 has been studied in one completed Phase 2 clinical trial, NCT02423408, titled "Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache." The trial enrolled 165 participants in the United States and was randomized, double-blind, and placebo-controlled.