Drug Database
ME

methadone

✓ Approved

Recordati S.p.A. · OPRD1 · Small Molecule

What is methadone?

methadone is a small molecule developed by Recordati S.p.A.. It is approved for therapeutic indications via oral (po).

Drug Profile

CompanyRecordati S.p.A.
Drug ClassSmall Molecule
Molecular TargetOPRD1, OPRK1, OPRM1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Recordati S.p.A.

Mechanism of Action

Molecular Targets

methadone acts on 3 molecular targets:

OPRD1opioid receptor delta 1 (DOR, OPRD)
OPRK1opioid receptor kappa 1 (KOR1, OPRK)
OPRM1opioid receptor mu 1 (MOR1, LMOR)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

methadone is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Psychiatric disordersDrug dependence✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Cancer pain✓ Approved

Related Research Articles

PubMedVeterinary journal (London, England : 1997)2026-10-14

Comparison of peribulbar anesthesia with neosaxitoxin or bupivacaine in dogs undergoing reconstructive keratoplasty.

Ribeiro M R MR, Ariga B K BK, Gomes D R DR, Alves D S DS et al.

This study compared the analgesic efficacy of peribulbar anesthesia using neosaxitoxin versus bupivacaine in dogs undergoing reconstructive keratoplasty. Of 28 dogs, four were excluded for not meeting the inclusion criteria. The anesthetic protocol included dexmedetomidine and methadone, propofol and isoflurane. Immediately after intubation, 24 dogs were randomly assigned (12 per group) to receive peribulbar block with either neosaxitoxin (3.5µg; NeoSTX group) or 0.5% bupivacaine (0.2mL/kg, Bupi group). Intraoperatively, cardiopulmonary variables and end-tidal isoflurane concentration (FE'ISO) were recorded at predefined time points. Pain, corneal esthesiometry, blepharospasm, and sedation were assessed preoperatively and up to 24hours post-extubation. Methadone was administered as rescue analgesia. The duration of analgesia, defined as the interval between block administration and the first rescue analgesia, was also recorded. Cardiopulmonary parameters, blepharospasm, duration of analgesia and sedation scores did not differ between treatments. The area under the curve (AUC) of Fe´ISO and esthesiometry were lower in the NeoSTX group compared to the Bupi group (P = 0.004; P = 0.009, respectively). Pain was lower in the Bupi group at 12hours post-extubation compared with the NeoSTX group (P = 0.012). Methadone was required in 4/12 dogs in each group, administered at 4-6hours post-extubation in the Bupi group and at 12-18hours in the NeoSTX group. In conclusion, at the dose and concentrations used in this study, peribulbar NeoSTX was associated with lower isoflurane and corneal esthesiometry AUCs, but did not provide additional postoperative analgesic benefit compared with bupivacaine.

PMID 42874844
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PubMedFrontiers in public health2026-10-14

Impact of opioid agonist therapies on non-fatal and fatal overdose: treatment patterns among individuals with opioid use disorder in Ontario, Canada.

Lee Kenneth K, Lam Vincent V, Nicolle Jennifer J, Drolet Martine M et al.

Although opioid agonist therapies (OAT) including buprenorphine extended-release (BUP-XR), transmucosal buprenorphine (TM-BUP), methadone and slow-release oral morphine (SROM) are effective and established medications for opioid use disorder (MOUD) available in Canada, differences in opioid-related overdose (OD) risk reduction across OAT types and patterns of treatment use are not well characterized. To assess the impact of OAT on opioid-related non-fatal and fatal OD among individuals with OUD in Ontario, Canada, and to examine patterns of OAT use. A retrospective, population-based, nested case-control study was conducted using ICES administrative health data. Adults with opioid use disorder (OUD) who were administered ≥1 OAT from January 2022 through June 2024 were included. Cases with opioid-related non-fatal or fatal OD were matched 1:10 to controls on age, sex, and follow-up duration. Adjusted odds ratios were estimated using weighted exact conditional logistic regression. Among 45,243 individuals with OUD who started OAT, 4,109 (9.1%) experienced a non-fatal OD and 770 (1.7%) had a fatal OD. Fatal OD cases were most commonly aged 35-49 years; non-fatal cases were most prevalent among those aged 18-34 years. Most OD cases were male and resided in urban areas. Substance use disorders other than OUD and anxiety disorders were more prevalent among OD cases than controls. Of non-fatal and fatal OD cases, 75.9% and 84.9% were not covered by an OAT for at least 80% of the time between cohort entry and index OD event, respectively. Of all OATs, BUP-XR had the lowest proportion of patients with non-fatal and fatal OD compared to no treatment. Both BUP-XR and TM-BUP were associated with significantly lower odds of non-fatal and fatal OD compared to no OAT, while methadone and SROM did not show similar improvements. OAT type and treatment continuity were associated with different OD risk reductions. Supporting sustained OAT engagement and expanding access to buprenorphine, including BUP-XR, may reduce non-fatal and fatal OD risk among individuals with OUD. Limitations include potential misclassification in administrative data, incomplete or inaccurate capture of opioid-related OD events and OAT use, and absence of a direct measure of OAT adherence.

PMID 42870957
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PubMedThe journal of behavioral health services & research2026-10-13

Health Information Technology Infrastructure and Availability of Medications for Opioid Use Disorder and Naloxone in U.S. Substance Use Disorder Treatment Facilities.

Carter Gregory A GA, Clifford Aidan A, Meyerson Beth E BE

Medications for opioid use disorder (MOUD) reduce overdose mortality, yet most individuals with opioid use disorder receive no pharmacotherapy. Facility-level health information technology may reflect broader organizational capacity, but it has rarely been examined as a marker associated with readiness to offer evidence-based opioid care. This cross-sectional secondary analysis of the 2024 National Substance Use and Mental Health Services Survey (N-SUMHSS) Public Use File included a base sample of 20,813 substance use disorder treatment facilities and used complete-case adjusted logistic regression to examine whether exclusive electronic health record (EHR) use, defined as reliance on an EHR with no paper charts, was associated with the availability of buprenorphine, naltrexone, take-home naloxone with overdose education, and co-occurring opioid use disorder services. Models adjusted for ownership, program focus, opioid treatment program (OTP) registration, and financial access characteristics; federally regulated OTP methadone availability served as a regulatory contrast. Among facilities with valid EHR responses (n = 16,107), 68.3% reported exclusive EHR use. Exclusive EHR use was associated with higher adjusted odds of buprenorphine (aOR = 3.05), naltrexone (aOR = 2.90), take-home naloxone with overdose education (aOR = 3.18), and co-occurring services (aOR = 2.33), and more weakly with federally regulated OTP methadone availability (aOR = 1.23). Exclusive EHR use is an organizational marker associated with service availability, but the cross-sectional design and potential residual confounding preclude causal conclusions about whether EHR investment would expand opioid treatment access.

PMID 42864480
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PubMedHealth services research2026-10-13

Impact of a National Stepped-Care Model of Opioid Use Disorder Treatment on Access to Medication Therapies Among Homeless-Experienced Veterans.

Li Haojia H, Baylis Jacob D JD, Huebler Sophia S, Gordon Adam J AJ et al.

To determine whether the Veterans Health Administration's (VHA) Stepped Care for Opioid Use Disorder Train-the-Trainer (SCOUTT) initiative increased medication treatment for opioid use disorder (MOUD) among persons experiencing homelessness (PEH). We conducted a national retrospective cohort study of MOUD, including buprenorphine, naltrexone, or methadone, in federal fiscal years (FY) 2016-2020. In late FY2018, VHA regional directors nominated facilities to receive SCOUTT implementation support to expand prescribing of MOUD (primarily buprenorphine) in select primary care, pain, and general mental health settings. We used mixed-effects quasi-Poisson regression models with entropy balancing to estimate the Average Treatment Effect on the Treated in the years after SCOUTT was implemented (FY2019-2020), controlling for pre-implementation levels of MOUD. Secondary analyses applied synthetic difference-in-differences (DiD) to estimate changes associated with SCOUTT. We used yearly pooled cross-sectional data from VHA electronic health records, FY2016-2020. The sample included annual cohorts of PEH with an opioid use disorder diagnosis and ≥ 1 primary care visit in the pre-implementation (FY2016-2018, n = 31,354) or post-implementation (FY2019-2020, n = 20,746) periods. From FY2016-2020, MOUD receipt increased more in SCOUTT facilities (n = 30, 45.0% to 61.1%) than in non-SCOUTT facilities (n = 811, 41.9% to 49.7%). In post-implementation years, PEH in SCOUTT facilities, compared to non-SCOUTT facilities, were more likely to receive any MOUD (risk difference [RD] = 6.16, 95% CI = 2.33-9.99), including buprenorphine (RD = 7.16, 95% CI = 4.35-9.97). There were no significant differences in methadone (RD = -0.19, 95% CI = -1.03-0.65) or naltrexone (RD = 0.10, 95% CI = -1.85-2.05). Synthetic DiD offered similar results: any MOUD DiD = 7.85, 95% CI = 2.15-13.55; buprenorphine DiD = 9.31, 95% CI = 3.56-15.06. A national initiative to advance a stepped-care model that encourages MOUD initiation outside specialty addiction settings improved access to buprenorphine among PEH. Similar initiatives could help to close treatment gaps in health care settings serving PEH.

PMID 42869778
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PubMedFrontiers in drug safety and regulation2026-10-13

Two decades of prescription opioid-related cardiovascular safety signals: a FAERS-based pharmacovigilance study using machine learning.

Ma Li L, Berryhill Johnna J, Ihrie John J, Chen Ru R et al.

Prescription opioids are essential for pain management but have been increasingly linked to cardiovascular adverse events. Understanding these risks is critical for informed prescribing opioid drugs. Approximately 18 million adverse event reports from 2004 Quarter 1 to 2024 Quarter 3 in the U.S. FDA Adverse Event Reporting System (FAERS) were downloaded and processed. RxNorm was used to normalize prescription opioid drug names. Empirical Bayes Geometric Mean analysis was then performed to detect signals of disproportionate reporting. Cardiovascular-related Preferred Terms from MedDRA were applied to identify drug-adverse event pairs. Unsupervised machine learning approaches, such as network analysis, hierarchical clustering, and Pearson correlation analysis were employed to study cardiovascular risk relationships among the prescription opioids. R code for the correlation analysis was generated with the assistance of a large language model (Claude, Anthropic) and verified by the authors. A total of 79,620 prescription opioid-cardiovascular adverse event pairs were identified, comprising 15 groups of FDA-approved prescription opioids and 291 unique cardiovascular adverse events. Fentanyl and oxycodone were the top two contributing drugs, while hypertension, hypotension, cardiac arrest, cardio-respiratory arrest, and tachycardia were the top five cardiovascular adverse events. The top 10 cardiovascular adverse events for each of the 15 groups of opioids were characterized. Network analysis and hierarchical clustering revealed close associations among fentanyl-remifentanil-sufentanil-morphine, hydrocodone-tramadol, and buprenorphine-oxymorphone-pentazocine based on shared cardiovascular adverse event profiles. The AI-assisted Pearson correlation heatmap further quantified pairwise profile similarities, identifying exceptionally strong correlations between pentazocine and buprenorphine (0.96), oxymorphone and methadone (r = 0.92), and between remifentanil and sufentanil (r = 0.91), and confirming the fentanyl-remifentanil-sufentanil-morphine cluster as the most internally coherent cardiovascular risk profiling group. This study provides the first large-scale, cardiovascular adverse events-focused pharmacovigilance analysis across FDA-approved prescription opioids using over two decades of FAERS data. The findings highlight the need for targeted cardiovascular risk assessment and monitoring, and support more refined prescribing practices and opioid safety labeling. The results showed that the integration of traditional Empirical Bayes signal detection with unsupervised machine learning may enable scalable pharmacovigilance analyses and uncover latent cardiovascular risk patterns that may be masked in broader adverse event assessments.

PMID 42865754
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PubMedAddiction (Abingdon, England)2026-10-12

Chronic pain treatment experiences and barriers among opioid agonist treatment participants who inject drugs: A qualitative study.

Yang Jie J, Walker Shelley S, McNeilage Amy G AG, Higgs Peter P et al.

Co-occurring chronic pain affects nearly half of people receiving opioid use disorder (OUD) treatment. Although this pain is often severe, it is usually inadequately managed. Stigma and clinical complexity associated with OUD are thought to further restrict access to pain care. This study examined barriers to pain treatment from the perspectives of people with both chronic pain and OUD. A qualitative study was conducted using semi-structured interviews with 20 adults with lived experience of chronic pain and opioid agonist treatment (OAT) (i.e. prescribed methadone or buprenorphine) for OUD, across three sites in Melbourne, Australia. Interviews were conducted in person, between December 2024 and February 2025. Interviews were audio-recorded and transcribed verbatim. NVivo 15 was used to manage and organise the transcripts. Data were analysed using reflexive thematic analysis informed by Levesque et al.'s patient-centred access to healthcare framework. Three interrelated themes were identified regarding barriers to accessing pain care among people with chronic pain and OUD. "Misalignment between health systems and everyday life" highlighted issues such as fragmented service delivery, limited coordination between pain and addiction services, and inconsistent pathways for referral and ongoing care. 'Stigma, distrust and exclusion in pain care' reflected participants' experiences of perceived and enacted stigma within healthcare settings, contributing to reduced help-seeking, delayed disclosure of pain and reluctance to engage with services. 'Deprioritised pain care in the context of OAT' illustrated how pain was often not systematically assessed or treated in addiction-focused care, with OUD frequently taking precedence over pain-related concerns. Pain care for people with opioid use disorder (OUD) appears to be influenced by intersecting structural, social and clinical barriers, including socioeconomic disadvantage and stigma. Pain management is reported as being deprioritised within OUD treatment contexts, with inconsistent attention to the assessment and treatment of chronic pain.

PMID 42860613
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