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Counseling +OTP
Counseling +OTP is a Small molecule drug developed by Friends Research Institute, Inc.. It is currently in Phase 3 development for Opioid use disorder. Also known as: Suboxone.
Counseling combined with opioid treatment program (OTP) provides behavioral therapy and medication-assisted treatment to reduce opioid use and support recovery.
Counseling +OTP is an intervention studied in clinical trials for conditions such as heroin addiction and opioid-use disorder. Docusate, a small molecule surfactant laxative, is the active ingredient in OTP.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 +OTP |
|---|---|
| Also known as | Suboxone |
| Sponsor | Friends Research Institute, Inc. |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Addiction Medicine |
| Phase | Phase 3 |
Mechanism of action
This is a combined psychosocial and pharmacological intervention for opioid use disorder. Counseling addresses behavioral, psychological, and social factors driving opioid dependence, while OTP (typically involving methadone or buprenorphine) reduces cravings and withdrawal symptoms. Together, they aim to improve treatment retention and long-term abstinence or controlled use outcomes.
Approved indications
- Opioid use disorder
Common side effects
- Withdrawal symptoms (if inadequately dosed)
- Constipation
- Sedation
- Nausea
Key clinical trials
- Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia (NA)
- Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment (EARLY_PHASE1)
- Buprenorphine for Prisoners (PHASE3)
- Effects of Cash Transfers on Severe Acute Malnutrition (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 +OTP CI brief — competitive landscape report
- Counseling +OTP updates RSS · CI watch RSS
- Friends Research Institute, Inc. portfolio CI
Frequently asked questions about Counseling +OTP
What is Counseling +OTP?
How does Counseling +OTP work?
What is Counseling +OTP used for?
Who makes Counseling +OTP?
Is Counseling +OTP also known as anything else?
What development phase is Counseling +OTP in?
What are the side effects of Counseling +OTP?
Related
- Manufacturer: Friends Research Institute, Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry / Addiction Medicine
- Indication: Drugs for Opioid use disorder
- Also known as: Suboxone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing