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TV-45070 · 3 trials · 3 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. |
| TV-45070 7% | EXPERIMENTAL | twice daily topical application to 7% body surface area for 7.5 days (15 applications) |
| TV-45070 21% | EXPERIMENTAL | twice daily topical application to 21% body surface area for 7.5 days (15 applications) |
| TV-45070 53% | EXPERIMENTAL | twice daily topical application to 53% body surface area for 7.5 days (15 applications) |
| 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...
TV-45070 is an investigational small molecule being studied for the treatment of osteoarthritis of the knee and postherpetic neuralgia. It is formulated as a topically applied ointment and has been evaluated in clinical trials for these conditions.
TV-45070 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA.
TV-45070 is in Phase 2 clinical development. It has completed Phase 2 trials for osteoarthritis of the knee and postherpetic neuralgia, as well as a Phase 1 pharmacokinetics study in healthy volunteers.
TV-45070 has completed three clinical trials. NCT02068599 was a Phase 2 study in 389 participants with osteoarthritis of the knee. NCT02365636 was a Phase 2 study in 300 patients with postherpetic neuralgia. NCT02215941 was a Phase 1 pharmacokinetics study in 45 healthy volunteers.
TV-45070 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development and has not been approved for any use.