Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TPM · 1 trial · 1 indication
Relating to repeated oral dosing
| Arm | Type | Description |
|---|---|---|
| Conversion-25 | EXPERIMENTAL | 25 mg |
| Conversion-50 | EXPERIMENTAL | 50 mg |
| Conversion-100 | EXPERIMENTAL | 100 mg |
| Conversion-200 | EXPERIMENTAL | 200 mg |
| Name | Type | Description |
|---|---|---|
| TPM XR | DRUG | Equivalent TDD in XR form, QD, Day 1-14 |
Inclusion Criteria: 1. Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR. 2. Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generaliz...
TPM is an investigational small molecule being developed for epilepsy. It is being studied as an adjunctive therapy in pediatric subjects with epilepsy. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
TPM is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SUPN. The company is conducting clinical trials to evaluate the drug's pharmacokinetics, safety, and tolerability in pediatric patients with epilepsy.
TPM is in Phase 1 clinical development. A Phase 1 trial has been completed, evaluating the drug as adjunctive therapy in pediatric subjects with epilepsy. The drug remains investigational and has not received FDA approval.
TPM has one completed clinical trial, NCT01284530, titled 'Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy.' This Phase 1 study enrolled 30 participants in the United States, including children aged 4 years and older.
Yes, TPM is also known as TPM XR. The clinical trial NCT01284530 refers to the drug as TPM XR, indicating it is an extended-release formulation of TPM. This alternative name is used in the context of the pediatric epilepsy study.