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Counseling + Methadone
Counseling + Methadone is a Opioid agonist (with behavioral intervention) Small molecule drug developed by Friends Research Institute, Inc.. It is currently in Phase 3 development for Opioid use disorder maintenance treatment, Opioid dependence.
Methadone is a synthetic opioid agonist that binds to mu opioid receptors in the central nervous system, while counseling provides behavioral and psychosocial support to address substance use disorder.
Methadone is a synthetic opioid agonist that binds to mu opioid receptors in the central nervous system, while counseling provides behavioral and psychosocial support to address substance use disorder. Used for Opioid use disorder maintenance treatment, Opioid dependence.
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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 | Counseling + Methadone |
|---|---|
| Sponsor | Friends Research Institute, Inc. |
| Drug class | Opioid agonist (with behavioral intervention) |
| Target | Mu opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Addiction Medicine / Substance Use Disorder |
| Phase | Phase 3 |
Mechanism of action
Methadone acts as a long-acting mu opioid receptor agonist, reducing withdrawal symptoms and cravings in opioid-dependent individuals through sustained receptor activation. The addition of counseling addresses the psychological and behavioral components of opioid use disorder, improving treatment adherence and outcomes through cognitive-behavioral therapy, motivational interviewing, and psychosocial support.
Approved indications
- Opioid use disorder maintenance treatment
- Opioid dependence
Common side effects
- Constipation
- Sedation
- Sweating
- Sexual dysfunction
- Weight gain
- QT prolongation
Key clinical trials
- E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder (PHASE2)
- Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics (NA)
- Autonomous Methadone Delivery System by Nurses (NA)
- Treating Polysubstance Use Using a Novel Digital Technology (PHASE3)
- Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence (NA)
- Screen, Treat and Retain People With Primary Meth Use Disorder at MMT Clinics (NA)
- Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT (NA)
- Fostering MAT Use in Justice Populations (NA)
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:
- Counseling + Methadone CI brief — competitive landscape report
- Counseling + Methadone updates RSS · CI watch RSS
- Friends Research Institute, Inc. portfolio CI
Frequently asked questions about Counseling + Methadone
What is Counseling + Methadone?
How does Counseling + Methadone work?
What is Counseling + Methadone used for?
Who makes Counseling + Methadone?
What drug class is Counseling + Methadone in?
What development phase is Counseling + Methadone in?
What are the side effects of Counseling + Methadone?
What does Counseling + Methadone target?
Related
- Drug class: All Opioid agonist (with behavioral intervention) drugs
- Target: All drugs targeting Mu opioid receptor
- Manufacturer: Friends Research Institute, Inc. — full pipeline
- Therapeutic area: All drugs in Addiction Medicine / Substance Use Disorder
- Indication: Drugs for Opioid use disorder maintenance treatment
- Indication: Drugs for Opioid dependence
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing