Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol/mL · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Tapentadol oral solution 4 mg/mL | DRUG | Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours. Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold. |
| Tapentadol oral solution 20 mg/mL | DRUG | Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours. |
| Placebo | OTHER | Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours. |
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | N/A | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | - | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | - | Flozin |
Tapentadol/mL is an investigational small molecule being studied for the treatment of acute pain. It is currently in Phase 3 clinical development. The drug is being evaluated in a clinical trial involving children and adolescents experiencing acute pain.
Tapentadol/mL is being developed by Assertio Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASRT. The company is conducting clinical research to evaluate the drug's safety and efficacy for acute pain management.
Tapentadol/mL is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under investigation for the treatment of acute pain.
Tapentadol/mL has one completed Phase 3 clinical trial registered as NCT02081391, titled 'A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain.' The trial enrolled 216 participants across multiple countries including the United States, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Poland, Spain, and the United Kingdom.
Tapentadol/mL is a formulation of tapentadol, an opioid analgesic, presented as an oral solution. The drug is being studied specifically in a pediatric population for acute pain. It is important to note that Tapentadol/mL is an investigational formulation and is not yet approved for use.