Approval Probability
TA Base Rate
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 developed by Bausch Health Companies Inc. (ticker: BHC) for gastrointestinal conditions. It has been studied in clinical trials for opioid-induced constipation and in healthy volunteer exposure studies. SP-333 is not approved and remains in clinical development.
SP-333 has been evaluated for the treatment of opioid-induced constipation (OIC). A Phase 2 dose-ranging study (NCT01983306) assessed its safety and efficacy in adults with OIC. The drug is investigational and has not been approved for any indication.
SP-333 is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company sponsored the clinical trials of SP-333, including a Phase 2 study in opioid-induced constipation and a Phase 1 study in healthy volunteers.
SP-333 is in Phase 2 development. A completed Phase 2 dose-ranging trial (NCT01983306) evaluated SP-333 for opioid-induced constipation. A Phase 1 single ascending dose study (NCT01705938) was also completed. SP-333 is investigational and not approved.
SP-333 has been studied in two completed trials: a Phase 2 dose-ranging study (NCT01983306) in 292 adults with opioid-induced constipation, and a Phase 1 single ascending dose study (NCT01705938) in 56 healthy adult subjects. Both trials were conducted in the United States.