Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP615 · 2 trials · 1 indication
Therapeutic success was defined as cessation of visible seizure activity within 10 minutes and sustained absence of visible seizure activity for 30 minutes following a single dose of SHP615 without the need for additional rescue medication. Number of participants with therapeutic success were reported.
Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to \<92 percent (%) measured up to 24 hours post-dose (i.e., \<92% on room air for 2 minutes or more after dosing while monitoring \[per healthcare setting protocol and/or the clinical judgment of the physician\]. ii) Increase in respiratory effort such that assisted ventilation is used (bag-valve-mask ventilation or endotracheal intubation). Number of participants with respiratory depression were reported.
Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication.
| Arm | Type | Description |
|---|---|---|
| SHP615 | EXPERIMENTAL | Participants will receive a single age-specific dose (approximately 0.25 to 0.5 milligram per kilogram \[mg/kg\] as midazolam) of SHP615 oromucosal solution through buccal route upon onset of seizures. |
| Name | Type | Description |
|---|---|---|
| SHP615 | DRUG | SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg). |
| MHOS/SHP615 | DRUG | MHOS/SHP615 |
Inclusion Criteria: * Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room, and are considered stable for discharge from the hospital. * Subjects who are greater than (\>) 6 months and less than (\<) 18 years...
SHP615 is an investigational small molecule being developed for nervous system diseases, specifically for convulsive status epilepticus in pediatric patients. It is formulated as a midazolam hydrochloride oromucosal solution for use in community and healthcare settings. The drug is currently in Phase 3 clinical development.
SHP615 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials for this drug in Japan, focusing on pediatric patients with convulsive status epilepticus.
SHP615 is in Phase 3 clinical development. Two Phase 3 trials have been completed, though the drug remains investigational and has not been approved. The trials enrolled a total of 28 pediatric patients, with no active trials currently ongoing.
SHP615 has been studied in two completed Phase 3 trials. NCT03336450 evaluated the drug in pediatric patients with convulsive status epilepticus in a community setting, enrolling 3 patients. NCT03336645 was an open-label study in a healthcare setting in Japan, enrolling 25 patients.
Yes, SHP615 is also known as midazolam hydrochloride oromucosal solution (MHOS). The clinical trials refer to the drug as MHOS/SHP615, indicating that SHP615 is the development code for this formulation of midazolam.