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Hydrocodone ER
Hydrocodone is an opioid agonist that binds to mu-opioid receptors in the central nervous system to reduce pain perception and provide analgesia.
Hydrocodone is an opioid agonist that binds to mu-opioid receptors in the central nervous system to reduce pain perception and provide analgesia. Used for Moderate to severe chronic pain requiring continuous opioid therapy.
At a glance
| Generic name | Hydrocodone ER |
|---|---|
| Also known as | CEP-33237, Hydrocodone bitartrate extended-release tablets, Hydrocodone bitartrate extended-release |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Opioid analgesic |
| Target | Mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Hydrocodone is a semi-synthetic opioid that acts as an agonist at mu-opioid receptors throughout the brain and spinal cord. By binding to these receptors, it modulates pain signal transmission and produces analgesic effects. The extended-release formulation is designed to provide sustained pain relief over an extended dosing interval.
Approved indications
- Moderate to severe chronic pain requiring continuous opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Respiratory depression
- Dependence/addiction risk
Key clinical trials
- A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain (PHASE2)
- To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules (PHASE1)
- A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery (PHASE2)
- Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) in Subjects With Renal Impairment (PHASE1)
- Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment (PHASE1)
- A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER) (PHASE1)
- Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets (PHASE3)
- Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hydrocodone ER CI brief — competitive landscape report
- Hydrocodone ER updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI