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IPX203
IPX203 is an extended-release combination of morphine and naltrexone designed to provide opioid analgesia while reducing the potential for abuse and addiction.
IPX203 is an extended-release combination of morphine and naltrexone designed to provide opioid analgesia while reducing the potential for abuse and addiction. Used for Moderate to severe chronic pain requiring around-the-clock opioid therapy.
At a glance
| Generic name | IPX203 |
|---|---|
| Also known as | IPX203 ER CD-LD Capsules |
| Sponsor | Impax Laboratories, LLC |
| Drug class | Opioid analgesic with abuse-deterrent properties |
| Target | Mu opioid receptor (morphine component); opioid receptors (naltrexone component) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
IPX203 combines morphine, an opioid analgesic, with naltrexone, an opioid antagonist, in an extended-release formulation. The naltrexone component is released gradually to discourage abuse via non-oral routes while allowing morphine to provide therapeutic pain relief when taken orally as directed. This abuse-deterrent approach aims to maintain analgesic efficacy while reducing misuse potential.
Approved indications
- Moderate to severe chronic pain requiring around-the-clock opioid therapy
Common side effects
- Constipation
- Nausea
- Dizziness
- Somnolence
- Headache
Key clinical trials
- BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease (PHASE4)
- A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease (PHASE4)
- Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations (PHASE3)
- A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations (PHASE3)
- A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease (PHASE2)
- A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease (PHASE2)
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:
- IPX203 CI brief — competitive landscape report
- IPX203 updates RSS · CI watch RSS
- Impax Laboratories, LLC portfolio CI