Last reviewed · How we verify
Morphine Sulphate Controlled Release
Morphine Sulphate Controlled Release is a Opioid analgesic Small molecule drug developed by Grünenthal GmbH. It is currently in Phase 3 development for Moderate to severe chronic pain, Cancer pain. Also known as: MST® CONTINUS®.
Morphine sulphate is an opioid agonist that binds to mu opioid receptors in the central nervous system to produce analgesia and pain relief.
Morphine Sulphate Controlled Release is used to treat conditions such as chronic pain, low back pain, and pain. It is not explicitly mentioned in the provided facts, but it is a type of controlled-release morphine, which is often used for pain management.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Morphine Sulphate Controlled Release |
|---|---|
| Also known as | MST® CONTINUS® |
| Sponsor | Grünenthal GmbH |
| Drug class | Opioid analgesic |
| Target | Mu opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Morphine acts as a mu opioid receptor agonist, binding to these receptors throughout the brain and spinal cord to modulate pain perception and transmission. The controlled-release formulation provides sustained drug delivery over an extended period, allowing for less frequent dosing compared to immediate-release formulations. This mechanism makes it effective for managing moderate to severe chronic pain.
Approved indications
- Moderate to severe chronic pain
- Cancer pain
Common side effects
- Constipation
- Nausea
- Drowsiness
- Dizziness
- Vomiting
- Respiratory depression
- Dependence/tolerance
Key clinical trials
- A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy (PHASE3)
- Opioid-Sparing Joint Replacement (PHASE3)
- Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery (NA)
- Clinical Decision Support to Improve System Naloxone Co-prescribing
- Effect of Stress Ball During Chest Tube Removal After Open Heart Surgery (NA)
- Erector Spinae Plane Block in Lumbar Release Surgery (NA)
- Opioid Use After Laparoscopic Salpingectomy (PHASE4)
- Efficacy of Methylprednisolone for Pain Control After ACL Repair (PHASE4)
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:
- Morphine Sulphate Controlled Release CI brief — competitive landscape report
- Morphine Sulphate Controlled Release updates RSS · CI watch RSS
- Grünenthal GmbH portfolio CI
Frequently asked questions about Morphine Sulphate Controlled Release
What is Morphine Sulphate Controlled Release?
How does Morphine Sulphate Controlled Release work?
What is Morphine Sulphate Controlled Release used for?
Who makes Morphine Sulphate Controlled Release?
Is Morphine Sulphate Controlled Release also known as anything else?
What drug class is Morphine Sulphate Controlled Release in?
What development phase is Morphine Sulphate Controlled Release in?
What are the side effects of Morphine Sulphate Controlled Release?
What does Morphine Sulphate Controlled Release target?
Related
- Drug class: All Opioid analgesic drugs
- Target: All drugs targeting Mu opioid receptor (OPRM1)
- Manufacturer: Grünenthal GmbH — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to severe chronic pain
- Indication: Drugs for Cancer pain
- Also known as: MST® CONTINUS®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing