Drugs / ALO-02
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pain agnosia | 2015-02-13 | “FDA has accepted for review the New Drug Application (NDA) for ALO-02” pfizer.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01775189 | Feb → Jul 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01557257 | Mar → May 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01571362 | Jun 2012 → Jun 2013 | chronic pain syndrome | Pfizer | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT02680847 | Jan 2016 → Jan 2018 | — | Pfizer | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2016-06-08 | Pfizer | Regulatory Pfizer Announces FDA Advisory Committees’ Recommend ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules for Approval pfizer.com ↗
The Committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. |
| 2015-02-13 | Pfizer | Regulatory Pfizer Announces FDA Acceptance for Review of a New Drug Application for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) pfizer.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALO-02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01775189 ↗ |
| Route | Oral | “Oral ALO-02 capsules (daily dose 20-160 mg oxycodone)” PMID 31849032 ↗ Sep 2019 |