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Important Information

Indivior may provide support in the form of funding and/or study medication for externally-sponsored studies that have gone through an internal review and approval process.

Before submitting a request for support, please review the information provided in the Submission Process section.

Please note that all required information must be included on the submission form prior to submitting it. It is not possible to save a partially completed form for completion at a later time.

For more information or questions, please contact the Indivior Externally Sponsored Studies team at investigationalstudies@indivior.com

Important Information

The request may be submitted either as a concept proposal or a full protocol.

If a concept proposal is submitted and subsequently endorsed to progress to the next stage of review, a full protocol must then be submitted for continued review and consideration of the request.

Requests must be submitted through this website

  • Submission through the website
  • Multi-stage review process
  • Supporting documents requested
  • Fully-executed signed contract
  • Study updates
  • Ongoing safety reporting and funding/study medication reconciliation
  • Provision of final study report and/or study-related publication
  • Study closeout

In determining if support may be provided, Indivior will consider whether the request aligns with the Indivior areas of research interest. Other factors that will be considered include:

  • Scientific validity and rationale
  • Sponsor qualifications
  • Research methodology that is objective, unbiased, balanced, and scientifically rigorous
  • Ability of the study sponsor to conduct a high quality, ethical study
  • A budget which includes reasonable costs that are consistent with fair market value

Full disclosure must be made of any external funding that is being sought or that will be received, in addition to any support being requested from Indivior.

Previous support from Indivior does not guarantee future support. Each request for support is evaluated based on its merits and in consideration of funding availability.

Upon favorable review of the full protocol, Indivior will require additional documentation before providing support (i.e., funding and/or study medication). Examples include (some may be country-specific):

  • Institutional review board/ethics committee approval
  • Full study protocol - if the final protocol is materially different from the approved protocol, Indivior reserves the right to reconsider providing support
  • Evidence that each investigator/sub-investigator has a current license to practice medicine, if applicable
  • Facility license for controlled substances, if applicable
  • Fully-executed signed contract
  • Curriculum vitae of all investigators and sub-investigators

Indivior requires that funding and study medication be used solely for the study for which it was approved.

Indivior also requires that study status updates be provided and that the investigator/sponsor meets all safety reporting obligations as per the fully-executed signed contract.

It is the responsibility of the investigator/sponsor to provide details of the registration of a clinical study with any required registry (e.g., ClinicalTrials.gov, EudraCT), as applicable.

An investigator/sponsor conducting an externally-sponsored study is contractually required to provide Indivior with a written report of the final study results, return any unused funds, and ensure appropriate disposition of unused study medication as instructed by Indivior.

Materials (e.g., abstract/manuscript) that will be submitted for publication must be provided to Indivior in advance of the submission in accordance with the fully-executed signed contract.

Areas of Research Interest

The information provided on this website regarding externally-sponsored studies is intended only for healthcare professionals, researchers, and scientists interested in submitting a study proposal to Indivior PLC or one of its subsidiaries (“Indivior”).

Indivior will consider providing funding and/or medicinal product for proposals/protocols that align with its areas of research interest.

For studies that include the use of an Indivior medicinal product, only proposals from countries in which the product is marketed will be considered.

Top view brain outline

SUBLOCADE®/SUBUTEX® Prolonged-release Injection

Indivior will consider providing funding and/or SUBLOCADE® (buprenorphine extended-release) injection for subcutaneous use (CIII)/SUBUTEX® Prolonged-release Injection for ESS Program proposals that align with its current areas of research interest.

  1. Regarding the treatment of opioid use disorder with SUBLOCADE®/SUBUTEX® Prolonged-release Injection, these are:
    • Improving treatment adherence; preventing/reducing relapse, overdose, and abuse/misuse/diversion
    • Evaluating long-term treatment outcomes (including real-world evidence, quality-of-life assessments, and health economic assessments)
    • Optimizing treatment/treatment strategies across the treatment continuum (i.e., initiation, maintenance, cessation)
    • Evaluation in special populations, sub-populations, patients at risk, and underserved patients
  2. Support of scientific research (utilizing SUBLOCADE®/SUBUTEX® Prolonged-release Injection) regarding substance use disorders (may include, but not limited to, opioid use disorder) to establish a proof of concept or to confirm mechanism of action
  3. Addressing unmet medical needs for patients with substance use disorders

SUBOXONE® (studies conducted outside of the United States only)

Indivior will consider providing funding and/or SUBOXONE® (buprenorphine and naloxone) sublingual film, for sublingual or buccal use, CIII for ESS proposals that align with its areas of research interest for studies conducted outside of the United States only.

  1. Regarding the treatment of opioid use disorder with SUBOXONE® sublingual film, these are:
    • Improving treatment adherence; preventing/reducing relapse and overdose
    • Evaluating long-term treatment outcomes (including real-world evidence, quality-of-life assessments, and health economic assessments)
    • Evaluation in sub-populations, patients at risk, and underserved patients
  2. Support of scientific research (utilizing SUBOXONE® sublingual film) regarding substance use disorders (may include, but not limited to, opioid use disorder) to establish a proof of concept or to confirm mechanism of action
  3. Addressing unmet medical needs for patients with substance use disorders

SUBLOCADE® and SUBOXONE® (studies conducted within the United States)

Indivior will consider providing support for the following:

  1. Studies that meet at least one of the applicable ESS areas of research interest for SUBLOCADE®, AND in which SUBOXONE® sublingual film or a generic transmucosal buprenorphine/naloxone product is proposed to be used only in the manner as described in the SUBLOCADE® US Prescribing Information for the purpose of initiating SUBLOCADE® treatment following induction and dose-adjustment with a transmucosal buprenorphine-containing product, may be considered for support in the form of funding, or SUBLOCADE® and SUBOXONE® sublingual film, or both funding and SUBLOCADE®/SUBOXONE®. SUBOXONE® sublingual film alone will not be provided.
  2. Studies that meet at least one of the applicable ESS areas of research interest for SUBLOCADE® AND in which SUBOXONE® sublingual film or a generic transmucosal buprenorphine/naloxone product is proposed to be used in a manner other than as described in the SUBLOCADE® US Prescribing Information for the purpose of initiating SUBLOCADE® treatment following induction and dose-adjustment with a transmucosal buprenorphine-containing product may be considered for support in the form of SUBLOCADE® only.
Blue blus sign with a dark blue atom-like shape in the background

OPVEE®

Indivior will consider providing funding and/or OPVEE® (nalmefene) nasal spray for ESS Program proposals that align with its current areas of research interest.

  1. Perspectives of patients and/or healthcare professionals on their lived experiences with OPVEE®
  2. Adverse event profile following the administration of OPVEE® compared to naloxone
  3. Health-economic impact of opioid overdose
  4. Comparative therapeutic efficacy/effectiveness (e.g., speed of onset, number of total doses required, total dose administered, total parenteral rescue dose administered) of OPVEE® to other opioid overdose treatment agents
  5. Evaluation in special populations, sub-populations, individuals at risk, and underserved patients
    • Criminal justice system population
    • Unintentional opioid exposure in individuals without opioid use disorder
  6. Impact of opioid overdose treatment on the initiation of, and retention on, medications for the treatment of opioid use disorder
  7. Incidence of re-narcotization following opioid overdose treatment
Head profile outline with blue plus sign in the middle

PERSERIS®

Indivior will consider providing funding and/or PERSERIS® (risperidone) for extended-release injectable suspension for subcutaneous use for ESS Program proposals that align with its current areas of research interest.

  1. Expanding therapeutic options for the treatment of schizophrenia with PERSERIS®
    • Improving treatment adherence
    • Continuity/transition of care
    • Broadening disease awareness (e.g., stigma, relapse prevention)
    • Reducing relapse, re-hospitalization, or length of hospital stay
    • Evaluating the transition from a current schizophrenia treatment medication to PERSERIS®
    • Treatment initiation in the emergency department
    • Adolescent patients (ages 13-17)
  2. Developing PERSERIS® treatment strategies with regard to:
    • Expanded treatment options for schizophrenia spectrum and other psychotic disorders (e.g., schizoaffective disorder, schizophreniform disorder, substance-/medication-induced psychotic disorder) and bipolar and related disorders
    • Innovative treatment options for co-morbid and/or stand-alone substance use disorders; e.g., cannabis-induced psychosis, increased relapse risk secondary to cannabis use in individuals with psychosis, stimulant (e.g., cocaine, methamphetamine) use disorder
  3. Evaluating PERSERIS® long-term treatment outcomes (e.g., real-world evidence, epidemiology, health-economic impact, and quality-of-life assessments)
  4. Evaluation and/or optimization of PERSERIS® treatment within the criminal justice system, the United States Veterans Health Administration, the United States Indian Health Service, or in indigenous peoples and communities

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