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Also known as funapide, XEN402
TV-45070 · 2 trials · 2 indications
The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be recorded (non-missing) or the daily average was considered missing. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.
The Western Ontario and McMasters Universities Arthritis Index \[WOMAC\] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee. It consists of 24 items separated into 3 domains (pain \[5 items\], stiffness \[2 items\], and physical function \[17 items\]). WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours. Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor.
| Arm | Type | Description |
|---|---|---|
| TV-45070 4% | EXPERIMENTAL | TV-45070 ointment in a 4% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28. |
| TV-45070 8% | EXPERIMENTAL | TV-45070 ointment in a 8% strength applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28. |
| Placebo | PLACEBO_COMPARATOR | Placebo ointment applied topically twice daily to the area of postherpetic neuralgia (PHN) pain during the treatment period from days 1 through 28. |
| Name | Type | Description |
|---|---|---|
| TV-45070 | DRUG | TV-45070 is an ointment applied topically twice daily to area of pain. |
| Placebo | DRUG | The matching placebo ointment contained only the excipients of the active treatment; also applied topically twice daily to area of pain. |
Inclusion Criteria: * Patient has chronic Postherpetic Neuralgia (PHN), defined as pain present for more than 6 months and less than 10 years after onset of herpes zoster skin rash affecting a single dermatome. Patients with more than 1 involved dermatome may also be included, provided the affected...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
TV-45070 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited as a topical ointment. It has been studied in Phase 2 clinical trials for two pain conditions: postherpetic neuralgia and primary osteoarthritis affecting a single knee. It is not an approved medicine and remains in clinical development.
TV-45070 has been evaluated for postherpetic neuralgia, a nerve pain condition that can follow shingles, and for osteoarthritis of the knee. Both uses were studied in Phase 2 trials, and the drug is investigational rather than approved for any indication.
TV-45070 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 2 clinical program testing the topical ointment in postherpetic neuralgia and knee osteoarthritis.
TV-45070 is in Phase 2 development. Two Phase 2 trials have been completed, one in postherpetic neuralgia and one in knee osteoarthritis, and no Phase 3 program has been reported. The drug is investigational and has not been approved by the FDA.
TV-45070 has been tested in two completed Phase 2 trials. NCT02365636 evaluated the topical ointment in 300 patients with postherpetic neuralgia in the United States. NCT02068599 tested it in 389 participants with primary osteoarthritis of a single knee, also in the United States. Both were randomized, double-blind, and placebo-controlled.
TV-45070 is a small molecule formulated as a topical ointment, meaning it is applied to the skin rather than taken systemically. It was studied for localized pain conditions, postherpetic neuralgia and knee osteoarthritis, with the goal of delivering treatment directly to the affected area.