Approval Probability
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Adjusted LOA
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AGN-214868 · 2 trials · 2 indications
The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).
Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.
| Arm | Type | Description |
|---|---|---|
| AGN-214868 total dose 500 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 500 ng on Day 1. |
| AGN-214868 total dose 1000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1. |
| AGN-214868 total dose 2000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1. |
| AGN-214868 total dose 6000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1. |
| AGN-214868 total dose 18000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1. |
| AGN-214868 total dose 60000 ng | EXPERIMENTAL | AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1. |
| Placebo to AGN-214868 | PLACEBO_COMPARATOR | Placebo to AGN-214868 injected into the bladder on Day 1. |
| AGN-214868 3.25 μg | EXPERIMENTAL | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment. |
| AGN-214868 16.25 μg | EXPERIMENTAL | AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment. |
| Placebo | PLACEBO_COMPARATOR | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
| Name | Type | Description |
|---|---|---|
| AGN-214868 | DRUG | AGN-214868 injected into the bladder. |
| AGN-214868 placebo | DRUG | AGN-214868 placebo injected into the bladder. |
| Placebo to AGN-214868 | DRUG | Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. |
Inclusion Criteria: * If female, must be of nonreproductive potential * If male, must agree to use acceptable contraception * Symptoms of overactive bladder with urinary urgency incontinence * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Cri...
AGN-214868 is an investigational small molecule being studied for postherpetic neuralgia and overactive bladder with urinary incontinence. It is in Phase 2 clinical development and is not approved by the FDA.
AGN-214868 is being developed by AbbVie Inc., traded on the New York Stock Exchange under the ticker ABBV.
AGN-214868 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA.
AGN-214868 has completed two Phase 2 trials. NCT01129531 studied 294 patients with postherpetic neuralgia in the US, Czechia, Germany, and Poland. NCT01157377 studied 160 patients with overactive bladder in the US, France, and the Netherlands.
AGN-214868 is the primary name for this investigational compound. No alternative names have been reported for it.