Approval Probability
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Adjusted LOA
ML Risk
SP-333 · 2 trials · 2 indications
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
| Arm | Type | Description |
|---|---|---|
| SP-333 1 mg | EXPERIMENTAL | 1 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 3 mg | EXPERIMENTAL | 3 mg SP-333 orally once daily for 4-week Treatment Period |
| SP-333 6 mg | EXPERIMENTAL | 6 mg SP-333 orally once daily for 4-week Treatment Period |
| Placebo | PLACEBO_COMPARATOR | Placebo orally once daily for 4-week Treatment Period |
| Group 1 | ACTIVE_COMPARATOR | SP-333 0.1 mg \& Placebo, one tablet by mouth, single dose |
| Group 2 | ACTIVE_COMPARATOR | SP-333 0.3 mg \& Placebo, 3 tablets by mouth, single dose |
| Group 3 | ACTIVE_COMPARATOR | SP-333 1 mg \& Placebo, one tablet by mouth, single dose |
| Group 4 | ACTIVE_COMPARATOR | SP-333 3 mg \& Placebo, 3 tablets by mouth,single dose |
| Group 5 | ACTIVE_COMPARATOR | SP-333 10 mg \& Placebo, 1 tablet by mouth, single dose |
| Group 6 | ACTIVE_COMPARATOR | SP-333 30 mg \& Placebo, 3 tablets by mouth, single dose |
| Group 7 | ACTIVE_COMPARATOR | SP-333 60 mg \& Placebo, 6 tablets by mouth, single dose |
| Name | Type | Description |
|---|---|---|
| SP-333 1 mg | DRUG | Tablet |
| SP-333 3 mg | DRUG | Tablet |
| SP-333 6 mg | DRUG | Tablet |
| Placebo | DRUG | Tablet |
| SP-333 | DRUG | - |
Inclusion Criteria: * Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening * Must have active OIC at screening * Active OIC must be confirmed during baseline screening bowel habit and symptom diary * Must be on stable diet Exclusion ...
SP-333 is an investigational small molecule being developed for gastrointestinal conditions, specifically for exposure and constipation. It is being studied for the treatment of opioid-induced constipation (OIC). The drug is currently in clinical development and is not approved by the FDA.
SP-333 is being developed by Bausch Health Companies Inc. (ticker: BHC). The company is conducting clinical trials to evaluate the safety and efficacy of SP-333 for gastrointestinal conditions, including opioid-induced constipation.
SP-333 is in Phase 2 clinical development. It has completed a Phase 1 study and a Phase 2 dose-ranging study for opioid-induced constipation. The drug is investigational and has not been approved by regulatory authorities.
SP-333 has been studied in two completed clinical trials. NCT01705938 was a Phase 1 single ascending dose study in healthy adults. NCT01983306 was a Phase 2 dose-ranging study for opioid-induced constipation. Both trials were conducted in the United States.
SP-333 is also known by its chemical name and is being developed under this identifier. No alternative brand names have been disclosed. It is a small molecule being investigated for gastrointestinal conditions.