Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Commercial Naproxen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Naproxen sodium ER (BAYH6689) | DRUG | Extented release Naproxen sodium (660mg) administered once a day |
| Commercial Naproxen (Aleve, BAYH6689) | DRUG | Immediate release Commercial Aleve (220mg) administered in a two ( 440 mg) plus one (220mg) dosing regime, 660 mg daily |
Inclusion Criteria: * Healthy ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/m2, and a total body weight \>50 kg (110 lbs) * Results of screening and clinical laboratory tests are within normal range or considered not clini...
Commercial Naproxen is a small molecule drug being developed for the treatment of pain. It is currently in Phase 1 clinical development, with one completed trial involving 32 participants in the United States.
Commercial Naproxen is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for pain.
Commercial Naproxen is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 1 trial with 32 participants.
Commercial Naproxen has one completed clinical trial, NCT00818415, titled 'Naproxen Sodium ER Pharmacokinetic Study.' This Phase 1 trial enrolled 32 participants in the United States and was active-controlled.
Commercial Naproxen is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with one completed trial. No approval status has been established.