benzhydrocodone
Trade name: Apadaz
Approved
Feb 23, 2018
Benzhydrocodone is an opioid prodrug of the morphinan class. Its chemical structure consists of hydrocodone coupled with benzoic acid. Benzhydrocodone itself is inactive and acts as a prodrug to hydrocodone upon cleavage of the benzoate portion of the molecule. — Wikipedia
Clinical trial activity
1 trials · 1 clinical orgs · 2 marketing orgs
Earliest trial started Oct 31, 2014 (NCT02462850)
Timeline
2010s
- Jan 1, 2014
Earliest Phase 3 Sponsor(trial)
- Feb 23, 2018
Kvk Tech Inc — Earliest FDA Approval
- Feb 23, 2018
Kvk Tech Inc — NDA Secondary Org
- Feb 23, 2018
Kvk Tech Inc — NDA Organization
- Feb 23, 2018
Zevra Therapeutics — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Mu opioid receptorAGONIST
OPRM agonist
Opioid receptors; mu/kappa/delta agonist
Highest affinity for the mu receptor which is primarily responsible for the analgesic activity.
Combination products
apadaz
with acetaminophen
Approval history
- approvedPriority reviewFeb 23, 2018
Chemistry & pharmacology
SMILES
COc1ccc2c3c1O[C@H]1C(OC(=O)c4ccccc4)=CC[C@@H]4[C@@H](C2)N(C)CC[C@@]341.Cl- Mol. weight
- 439.94 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaBenzhydrocodone ↗
- ChEMBLCHEMBL3137321 ↗
- ChEMBLCHEMBL3137310 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02462850 | Phase 3 | Oct 31, 2014 | Charleston Laboratories, Inc |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Charleston Laboratories, Inc | For profit | 1 | 1 | 1 | 2014 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Kvk Tech Inc | For profit | NDA2 | Feb 23, 2018 |
| Kvk Tech Inc | For profit | NDA | Feb 23, 2018 |
| Zevra Therapeutics | For profit | NDA2 | Feb 23, 2018 |