Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALO-01 · 2 trials · 3 indications
Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
| Arm | Type | Description |
|---|---|---|
| ALO-01 | EXPERIMENTAL | Doses given once or twice daily |
| Placebo | PLACEBO_COMPARATOR | Twice a day (bid) |
| Name | Type | Description |
|---|---|---|
| ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) | DRUG | capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily |
| ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) | DRUG | capsules, up to 80 mg bid |
| Placebo | DRUG | capsules, bid |
Inclusion Criteria: * Subject 18-70 years of age * Subject agrees to refrain from taking any opioid medications other than study medication during study period. * History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline Exclusion Criteri...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
ALO-01 is an investigational extended-release pain medicine developed by Pfizer, Inc. (NYSE: PFE). It combines morphine sulfate with naltrexone hydrochloride in a single small-molecule formulation. It has been studied in Phase 3 clinical trials for chronic pain, including pain due to osteoarthritis of the hip or knee.
ALO-01 was studied for the treatment of chronic moderate to severe pain, including pain caused by osteoarthritis of the hip or knee. Its Phase 3 program enrolled adults with osteoarthritis and other chronic nonmalignant pain conditions. It is an investigational therapy and is not described as approved for these uses.
Pfizer, Inc. (NYSE: PFE) is the developer of ALO-01. Pfizer sponsored the Phase 3 clinical trials evaluating the extended-release morphine sulfate plus naltrexone hydrochloride combination in patients with chronic pain, including osteoarthritis-related pain.
ALO-01 has been evaluated in Phase 3 clinical development. Its Phase 3 trials in chronic pain and osteoarthritis are listed as completed, and no trials are currently active. It is an investigational product rather than a marketed medicine.
ALO-01 has been studied in two completed Phase 3 trials. NCT00420992 evaluated it in 547 subjects with pain due to osteoarthritis of the hip or knee in the United States. NCT00415597 studied it in 467 subjects with chronic moderate to severe nonmalignant pain, also in the United States.
Yes. ALO-01 is also known as Embeda and Kadian NT, and is described as morphine sulfate plus naltrexone hydrochloride extended release. These names refer to the same Pfizer-developed combination product studied in Phase 3 trials for chronic pain and osteoarthritis.