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Also known as ALO-02 (Oxycodone Naltrexone), Oxycodone controlled-release test formulation
ALO-02 · 2 trials · 4 indications
Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
| Arm | Type | Description |
|---|---|---|
| ALO-02 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 40 mg ALO-02 capsule | EXPERIMENTAL | Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block |
| 80 mg ALO-02 capsule | EXPERIMENTAL | Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block |
| 40 mg OxyContin tablet | EXPERIMENTAL | Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block |
| Name | Type | Description |
|---|---|---|
| ALO-02 | DRUG | 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily |
| Placebo | DRUG | oral placebo, divided into symmetric doses and administered twice daily |
| Naltrexone block | DRUG | Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing |
| OxyContin | DRUG | Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily) |
Inclusion Criteria: * Moderate-to-severe chronic low back pain present for at least 3 months. * Require a continuous around-the-clock opioid analgesic for an extended period of time. * Refrain from taking other opioid and non-opioid medications during the study. Exclusion Criteria: * Active or wi...
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
ALO-02 is being developed for the management of moderate to severe chronic pain, including chronic low back pain. It is an investigational small molecule product studied in adults 18 years and older. It has not been approved for any indication and remains in clinical development.
ALO-02 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the product in patients with moderate to severe chronic low back pain.
ALO-02 has completed a Phase 3 clinical trial and is not currently listed with any active trials. The Phase 3 study was a randomized, double-blind, placebo-controlled trial in patients with moderate to severe chronic low back pain. ALO-02 is investigational and has not been approved by the FDA.
ALO-02 has been studied in two completed trials. The Phase 3 trial NCT01571362 enrolled 410 adults with moderate to severe chronic low back pain in the United States. The Phase 1 pharmacokinetics trial NCT01557257 compared ALO-02 with OxyContin in 13 healthy volunteers.
Yes. ALO-02 is also known as oxycodone naltrexone, reflecting its composition of oxycodone hydrochloride and naltrexone hydrochloride. The Phase 3 trial title lists the drug as ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), so searches for either name refer to the same investigational product.