INDIVIOR_ScienceDay_PublicationPublications

Information about sponsored clinical trials and result information are provided for informational purposes only and are not intended to promote any product or use. Clinical study results are intended to report the results of the study that were known at the time of the study’s completion. The results therefore do not provide a comprehensive and current review of the safety and efficacy of any drug based upon all information available. Physicians and patients should refer to the current approved product labeling for information on approved indications in their country.

This information is not intended to replace the advice of a health care professional. Only a physician can determine if a specific medicine is the correct or best treatment option for a particular patient. If you have questions, please consult a health care professional.

Our mission is to discover and develop innovative medications that help transform patients’ lives through our industry-leading understanding of addiction and the chronic conditions and co-occurring disorders of addiction

We are constantly investigating new areas of understanding, new approaches to addiction treatment and new methodologies to support measurement of clinical response. Our latest thinking, journals and studies in these areas include:

R&D Peer-Reviewed Publications – PDF Version

Treatment of Substance Use Disorder

Indivior: pioneering research and development in the treatment of addictions

AUTHOR
Christian Heidbreder, Rolley E. Johnson, Chris Chapleo and Paul J. Fudala

PUBLISHERS
Nature, 522 (7557): Supp. S45-S63

> http://bit.ly/1QuufKi

Treatment of Opioid Use Disorder

A population pharmacokinetic and pharmacodynamic modelling approach to support the clinical development of rbp-6000, a new, subcutaneously injectable, long-acting, sustained-release formulation of buprenorphine, for the treatment of opioid dependence

AUTHOR
Nasser AF, Heidbreder C, Gomeni R, Fudala PJ, Zheng B, Greenwald MK (2014)

PUBLISHERS
J. Clin. Pharmacokinetics, 53(9): 813-824

> http://bit.ly/1l7vUJN

 

Pharmacokinetics of sublingual buprenorphine and naloxone in subjects with mild to severe hepatic impairment (child-pugh classes a, b, and c), in hepatitis c virus-seropositive subjects, and in healthy volunteers

AUTHOR
Nasser A, Heidbreder C, Liu Y, Fudala PJ (2015)

PUBLISHERS
J. Clin. Pharmacokinetics, 54(8): 837-849

> http://bit.ly/1NdyhkR

 

Population pharmacokinetic modelling after repeated administrations of RBP-6000, a new, subcutaneously injectable, long-acting, sustained-release formulation of buprenorphine, for the treatment of opioid use disorder

AUTHOR
Laffont CM, Gomeni R, Heidbreder C, Jones JP 3rd, Nasser AF (2015)

PUBLISHERS
J. Clin. Pharmacol., Oct 19th, Electronic publication ahead of print

> http://bit.ly/1WRtKJS

Treatment of Psychiatric Co-Morbidities

Population pharmacokinetics and prediction of dopamine d2 receptor occupancy after multiple doses of rbp–7000, a new sustained–release formulation of risperidone, in schizophrenia patients on stable oral risperidone treatment

AUTHOR
Laffont CM, Gomeni R, Heidbreder C, Fudala PJ, Nasser AF (2014)

PUBLISHERS
Clin. Pharmacokinetics, 53(6): 533-543

> http://bit.ly/1iCNJ1v

Rescue Medications

Liquid chromatography/tandem mass spectrometry method for simultaneous determination of cocaine and its metabolite(−)ecgonine methyl ester in human acidified stabilized plasma samples

AUTHOR
Liu Y, Zheng B, Strafford S, Orugunty R, Sullivan M, Gus J, Heidbreder C, Fudala PJ, Nasser A (2014)

PUBLISHERS
J. Chromatogr. B. 961: 77-85

> http://bit.ly/1Rv24sU

 

A randomized, double-blind, placebo-controlled trial of RBP-8000 in cocaine abusers: Pharmacokinetic profile of RBP-8000 and cocaine and effects of RBP-8000 on cocaine-induced Physiological effects

AUTHOR
Nasser A, Fudala PJ, Zheng B, Liu Y, Chen Y, Heidbreder C (2014)

PUBLISHERS
J Addict Dis., 33(4): 289-302

> http://bit.ly/1NPIGpN

Early Stage Discovery & Development

Rationale in support of the use of selective dopamine D3 receptor antagonists for the pharmacotherapeutic management of drug addiction

AUTHOR
Heidbreder C (2013)

PUBLISHERS
Naunyn-Schmiedeberg’s Archives of Pharmacology, 386: 167-176

> http://bit.ly/1MHf9RW

 

OTHER ARTICLES:

Micheli F, Heidbreder C (2013) Selective dopamine D3 receptor antagonists 2007-2012: A patent review. Expert Opin. Ther. Patents, 23(3):363-381. http://dx.doi.org/10.1517/13543776.2013.757593

Gomeni R., Heidbreder C, Fudala PJ, Nasser AF (2013) A model-based approach to characterize the population pharmacokinetics and the relationship between the pharmacokinetic and safety profiles of RBP-7000, a new, long-acting, sustained-release formulation of risperidone. J. Clin. Pharmacol., 53(10):1010-1019. http://dx.doi.org/10.1002/jcph.141

Laffont CM, Gomeni R, Zheng B, Heidbreder C, Fudala PJ, Nasser AF (2015) Population pharmacokinetic modeling and simulation to guide dose selection for RBP-7000, a new sustained-release formulation of risperidone. J. Clin. Pharmacol., 55(1):93-103. http://dx.doi.org/10.1002/jcph.366

 

R&D Published Conference Abstracts

  1. Gomeni, R., Heidbreder, C., Fudala, P.J., Nasser, A. (2013) A model-based approach to characterize the relationship between the long-lasting pharmacokinetic (pk) time-course and the safety profile of RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Indianapolis, March 5th-9th.
  2. Gomeni, R., Heidbreder, C., Fudala, P.J., Nasser, A. (2013) A model-based approach to characterize the long-lasting pharmacokinetic (pk) time-course of RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Indianapolis, March 5th-9th.
  3. Gomeni, R., Laffont,C.M., Zheng, B., Heidbreder, C., Fudala, P.J., Nasser, A. (2014) A dose-switching simulation analysis from INVEGA® SUSTENNA® (paliperidone palmitate) or RISPERDAL® CONSTA® to RBP-7000, a new sustained released formulation of risperidone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  4. Nasser, A., Heidbreder, C., Fudala, P.J., Sutton, H., Zheng, B., Greenwald, M.K. (2014) A model-based approach to evaluate the PK and mu-opioid receptor occupancy of RBP-6000, a once monthly depot formulation of buprenorphine. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  5. Min, L., Heidbreder, C., Fudala, P.J., Nasser, A. (2014) A model-based approach to characterize risperidone release, absorption, and disposition after administration of RBP-7000 in schizophrenic patients. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  6. Zheng, B., Liu, Y., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A model-based approach to predict plasma/brain cocaine levels following RBP-8000, a double mutant bacterial cocaine esterase, administration in humans. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  7. Chen, Y., Zheng, B., Liu, Y., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A double-blind, placebo-controlled study to evaluate the effects of RBP-8000 on cocaine PK and cocaine-induced physiological effects in cocaine users. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  8. Li, M., Heidbreder, C., Fudala, P.J., Nasser A. (2014) A model-based approach to characterize risperidone release, absorption, and disposition after administration of RBP-7000 in schizophrenic patients. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), Atlanta, March 18th-22nd.
  9. Laffont C.M., Gomeni R. , Zheng B. , Heidbreder C., Fudala P.J., Nasser A.F. (2014) Population PK modeling and simulation to support dose selection of RBP-7000, a new sustained-release formulation of risperidone, in schizophrenic patients. Proceedings of the 23rd Meeting of the Population Approach Group in Europe (PAGE), Alicante, Spain, June 10th-13th.
  10. Jones J.P. III, Fudala, P.J., Heidbreder, C., Nasser A. (2015) Modeling and simulation to evaluate possible consequences of dose dumping for rbp-7000, a new sustained-release formulation of risperidone (Ris). Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), New Orleans, March 3rd-7th.
  11. Jones J.P. III, Liu, Y., Fudala, P.J., Heidbreder, C., Nasser A. (2015) The effect of hepatic impairment (HI) or HCV infection on the pharmacokinetics (PK) of buprenorphine and naloxone. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), New Orleans, March 3rd-7th.
  12. Jia, H., Greenwald, M.K., Vince, B., Fudala, P.J., Heidbreder, C., Nasser A. (2015) A multiple-dose study of blockade of opioid subjective effects by subcutaneous injections of depot buprenorphine in subjects with opioid use disorder. Proceedings of the American Society for Clinical Pharmacology & Therapeutics (ASCPT), New Orleans, March 3rd-7th.