Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADL5859 · 4 trials · 5 indications
The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment group as a main factor and baseline NPRS score as a covariate. Change from Baseline = NPRS at baseline - NPRS at Week 4; a positive number in the LS mean indicates a reduction in pain intensity from baseline.
Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose. Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence.
Participants assessed their "Now" LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline "Now" LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary.
| Arm | Type | Description |
|---|---|---|
| ADL5859 | EXPERIMENTAL | One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days |
| ADL5747 | EXPERIMENTAL | One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days |
| Oxycodone CR | ACTIVE_COMPARATOR | One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14 |
| Placebo | PLACEBO_COMPARATOR | Four placebo capsules administered orally BID for 14 days |
| Duloxetine | ACTIVE_COMPARATOR | 2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days |
| ADL5859 -- 200 mg (Part A) | EXPERIMENTAL | ADL5859: 200 milligrams (mg), capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study |
| Naproxen -- 500 mg (Part A) | ACTIVE_COMPARATOR | Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study |
| Placebo (Part A) | PLACEBO_COMPARATOR | Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study |
| ADL5859 - 100 mg (Part B) | EXPERIMENTAL | ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study |
| Placebo (Part B) | PLACEBO_COMPARATOR | Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study |
| ADL5859 30 mg | EXPERIMENTAL | - |
| ADL5859 100 mg | EXPERIMENTAL | - |
| ADL5859 200 mg | EXPERIMENTAL | - |
| ibuprofen 400 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ADL5859 | DRUG | - |
| ADL5747 | DRUG | - |
| Oxycodone CR | DRUG | - |
| Placebo | DRUG | - |
| Duloxetine | DRUG | - |
| Naproxen | DRUG | - |
| ADL5859 30 mg | DRUG | single dose |
| ADL5859 100 mg | DRUG | single dose |
| ADL5859 200 mg | DRUG | single dose |
| ibuprofen 400 mg | DRUG | single dose |
Key Inclusion Criteria: * a man or woman between 18 and 75 years of age, inclusive * for women of childbearing potential, be using an insertable, injectable, transdermal, or combination oral contraceptive deemed highly effective by the United States Food and Drug Administration from the first dose ...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
ADL5859 is an investigational small molecule drug developed by Merck & Company, Inc. (MRK) for the treatment of pain. It has been studied in Phase 2 clinical trials for acute pain, osteoarthritis of the knee, peripheral neuropathy, and rheumatoid arthritis.
ADL5859 was studied for the treatment of acute pain, osteoarthritis of the knee, peripheral neuropathy, and rheumatoid arthritis. It is an investigational drug and has not been approved for any indication.
ADL5859 is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck conducted the clinical development program for this investigational pain drug.
ADL5859 is in Phase 2 clinical development. It has completed Phase 2 trials but has not advanced to Phase 3, and it is not FDA approved.
ADL5859 has been evaluated in completed Phase 2 trials including NCT00993863 for acute dental pain, NCT00979953 for osteoarthritis of the knee, NCT00626275 for rheumatoid arthritis, and NCT00603265 for diabetic peripheral neuropathy.