Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALO-02 · 3 trials · 5 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 |
| A | EXPERIMENTAL | 1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions. |
| B | EXPERIMENTAL | 1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast). |
| C | EXPERIMENTAL | 1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions. |
| 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) |
| ALO-02 (Oxycodone Naltrexone) | DRUG | single dose of ALO-02 capsule under fasting condition |
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...
ALO-02 is an investigational small molecule being developed for the management of moderate to severe pain, including chronic low back pain. It has been studied in healthy volunteers for pharmacokinetic assessments. The drug is a combination of oxycodone hydrochloride and naltrexone hydrochloride in an extended release formulation.
ALO-02 is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted clinical trials of ALO-02 in the United States for pain management indications.
ALO-02 has completed a Phase 3 clinical trial for chronic low back pain. It is an investigational drug and remains in clinical development. The Phase 3 study evaluated the drug in patients with moderate to severe chronic low back pain.
ALO-02 has been studied in three completed clinical trials. NCT01456507 was a Phase 1 healthy volunteers study of food effects, NCT01557257 was a Phase 1 pharmacokinetics study versus OxyContin, and NCT01571362 was a Phase 3 study in chronic low back pain with 410 participants.
ALO-02 is not the same as OxyContin. ALO-02 contains oxycodone and naltrexone in an extended release formulation, while OxyContin contains only oxycodone. A Phase 1 study compared the pharmacokinetics of ALO-02 and OxyContin.
ALO-02 contains oxycodone, an opioid agonist, and naltrexone, an opioid antagonist. The naltrexone is sequestered in the formulation to deter abuse. When taken as directed, oxycodone provides pain relief, while the naltrexone is intended to be released if the drug is crushed.