Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DPH · 2 trials · 1 indication
WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.
| Arm | Type | Description |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | EXPERIMENTAL | - |
| Naproxen Sodium 440 mg (BAYH6689) | ACTIVE_COMPARATOR | - |
| DPH 50 mg | ACTIVE_COMPARATOR | - |
| Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) | EXPERIMENTAL | - |
| Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111) | DRUG | Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally. |
| Naproxen Sodium 440 mg (BAYH6689) | DRUG | Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally. |
| DPH 50 mg | DRUG | Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally. |
| Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) | DRUG | Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose |
| Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) | DRUG | Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose |
Inclusion Criteria: * Healthy, ambulatory, male and female volunteers ages 12 and older * Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the follo...
DPH is used for the treatment of postoperative pain, specifically postsurgical dental pain. It is a small molecule being developed by Bayer AG as an analgesic and sedative combination therapy. The drug is currently in Phase 3 clinical development, with two completed trials evaluating its efficacy in patients with postsurgical dental pain.
DPH is a combination of naproxen sodium and diphenhydramine. Naproxen sodium is a nonsteroidal anti-inflammatory drug that targets cyclooxygenase enzymes to reduce pain and inflammation, while diphenhydramine is an antihistamine with sedative properties. The combination is designed to provide both analgesic and sedative effects for postoperative pain management.
DPH is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting Phase 3 clinical trials to evaluate the efficacy and safety of DPH for the treatment of postsurgical dental pain.
DPH is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total enrollment of 979 patients. Both trials were randomized, double-blind, and active-controlled, evaluating the analgesic and sedative efficacy of naproxen sodium and diphenhydramine in patients with postsurgical dental pain. DPH is not yet approved and remains investigational.
DPH has been evaluated in two completed Phase 3 clinical trials. The first trial, NCT01280591, enrolled 712 patients with postsurgical dental pain in the United States. The second trial, NCT01495858, enrolled 267 patients. Both trials were randomized, double-blind, and active-controlled, assessing the analgesic and sedative efficacy of naproxen sodium and diphenhydramine.
DPH is a combination product containing naproxen sodium and diphenhydramine. It is not the same as either drug alone, but rather a fixed-dose combination designed to provide both analgesic and sedative effects. The combination is being studied specifically for the management of postoperative pain following dental surgery.