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

Early Stage Discovery & Development

  1. Heidbreder C (2013) Rationale in support of the use of selective dopamine D3 receptor antagonists for the pharmacotherapeutic management of drug addiction. Naunyn-Schmiedeberg’s Archives of Pharmacology, 386: 167-176. http://dx.doi.org/10.1007/s00210-012-0803-6
  2. 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
  3. Rice OV, Heidbreder CA, Gardner EL, Schonhar C, Ashby CR Jr. (2013) The selective D3 receptor antagonist SB-277011A attenuates morphine-triggered reactivation of expression of cocaine-induced conditioned place preference. Synapse, 67(8):469-475. http://dx.doi.org/10.1002/syn.21653
  4. Ashby C, Rice O, Heidbreder C, Gardner E (2015) The selective dopamine D3 receptor antagonist SB-277011A attenuates drug- or food deprivation reactivation of expression of conditioned place preference for cocaine in male Sprague-Dawley rats. Synapse, 69(6):336-345. http://dx.doi.org/10.1002/syn.21820
  5. Ashby C, Rice O, Heidbreder C, Gardner E (2015) The Selective Dopamine D3 Receptor Antagonist SB-277011A Significantly Accelerates Extinction to Environmental Cues Associated with Cocaine-Induced Place Preference in Male Sprague-Dawley Rats. Synapse, 69(10):512-514. http://dx.doi.org/10.1002/syn.21839
  6. Micheli F, Cremonesi S, Semeraro T, Tarsi L, Tomelleri S, Cavanni P, Zonzini L, Feriani A, Braggio S, Heidbreder C (2016) Novel morpholine scaffolds as selective dopamine (DA) D3 receptor antagonists. Bioorganic & Medicinal Chemistry, 26(4): 1329-1332. http://dx.doi.org/10.1016/j.bmcl.2015.12.081
  7. Micheli F, Bernardelli A, Bianchi F, Braggio S, Castelletti L, Cavallini P, Cavanni P, Cremonesi S, Cin MD, Feriani A, Oliosi B, Semeraro T, Tarsi L, Tomelleri S, Wong A, Visentini F, Zonzini L, Heidbreder C (2016) 1,2,4-Triazolyl Octahydropyrrolo[2,3‐b]pyrroles: A New Series of Potent and Selective Dopamine D3 Receptor Antagonists. Bioorganic & Medicinal Chemistry, 24(8): 1619-1636. http://dx.doi.org/10.1016/j.bmc.2016.02.031
  8. Micheli F, Bacchi A, Bernardelli A, Braggio S, Castelletti L, Cavallini P, Cavanni P, Cremonesi S, Dal Cin M, Feriani A, Kajbaf M, Marchió L, Oliosi B, Pellacani A, Perdona E, Sava A, Semeraro T, Tarsi L, Tomelleri S, Wong A, Visentini F, Zonzini L, Heidbreder C (2016) 1,2,4-Triazolyl 5-Azaspiro[2.4]heptanes: Lead Identification and Early Lead Optimization of a New Series of Potent and Selective Dopamine D3 Receptor Antagonists. Med. Chem., 59(18):8549-8576. http://dx.doi.org/10.1021/acs.jmedchem.6b00972

 

Treatment of Schizophrenia

  1. 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-released formulation of risperidone. Clin. Pharmacol., 53(10):1010-1019. http://dx.doi.org/10.1002/jcph.141
  2. Laffont CM, Gomeni R, Heidbreder C, Fudala PJ, Nasser AF (2014) 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. Pharmacokinetics, 53(6):533-543. http://dx.doi.org/10.1007/s40262-014-0132-7
  3. 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. Clin. Pharmacol., 55(1):93-103. http://dx.doi.org/10.1002/jcph.366
  4. Nasser AF, Henderson DC, Fava M, Fudala PJ, Twumasi-Ankrah P, Kouassi A, Heidbreder C (2016) Efficacy, safety and tolerability of RBP-7000 once monthly risperidone for the treatment of acute schizophrenia: An 8-week, randomized, double-blind, placebo-controlled, multicenter Phase 3 study. Clin. Psychopharmacology, 36(2):130-140. http://dx.doi.org/10.1097/JCP.0000000000000479
  5. Isitt JJ, Nadipelli VR, Kouassi A, Fava M, Heidbreder C (2016) Health-related quality of life in acute schizophrenia patients treated with RBP-7000 once monthly risperidone: An 8-week, randomized, double-blind, placebo-controlled, multicenter phase 3 study. Schizophr Res., 174(1-3):126-131. http://dx.doi.org/10.1016/j.schres.2016.03.020
  6. Ivatori V, Gobburu J, Gopalakrishnan M, Zhang W, Jones JP III, Yongzhen L, Twumasi-Ankrah P, Heidbreder C, Laffont C (2017) Exposure Response Analysis for a New Once a Month Long Acting Risperidone. J. Clin. Pharmacol., 83(7):1476-1498. http://dx.doi.org/10.1111/bcp.13246

 

Treatment of Substance Use Disorder

  1. Bani M, Andorn A, Heidbreder C (2014) Pharmacologically, are smokers the same as non-smokers? Opin. Pharmacol., 14:42-49. http://dx.doi.org/10.1016/j.coph.2013.11.003

 

Rescue Medications

  1. Liu Y, Zheng B, Strafford S, Orugunty R, Sullivan M, Gus J, Heidbreder C, Fudala PJ, Nasser A (2014) Liquid chromatography/tandem mass spectrometry method for simultaneous determination of cocaine and its metabolite (−)ecgonine methyl ester in human acidified stabilized plasma samples. Chromatogr. B., 961:77-85. http://dx.doi.org/10.1016/j.jchromb.2014.04.052
  2. Nasser A, Fudala PJ, Zheng B, Liu Y, Chen Y, Heidbreder C (2014) 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. J Addict Dis., 33(4):289-302. http://dx.doi.org/10.1080/10550887.2014.969603

 

Treatment of Opioid Use Disorder

  1. Nasser AF, Heidbreder C, Gomeni R, Fudala PJ, Zheng B, Greenwald MK (2014) 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. Pharmacokinetics, 53(9):813-824. http://dx.doi.org/10.1007/s40262-014-0155-0
  2. Nasser A, Heidbreder C, Liu Y, Fudala PJ (2015) 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. Pharmacokinetics, 54(8): 837-849. http://dx.doi.org/10.1007/s40262-015-0238-6
  3. Liu Y, Li X, Xu A, Heidbreder C, Nasser AF (2016) Simultaneous determination of buprenorphine, norbuprenorphine and naloxone in human plasma by liquid chromatography/tandem mass spectrometry. Pharm. Biomed. Analysis, 120:142-152. http://dx.doi.org/10.1016/j.jpba.2015.12.008
  4. Nasser AF, Greenwald MK, Vince B, Fudala PJ, Twumasi-Ankrah P, Liu Y, Jones JP III, Heidbreder C (2016) Sustained-Release Buprenorphine (RBP-6000) Blocks the Effects of Opioid Challenge with Hydromorphone in Subjects with Opioid Use Disorder. J Clin Psychopharmacol., 36(1):18-26. http://dx.doi.org/10.1097/JCP.0000000000000434
  5. Laffont CM, Gomeni R, Heidbreder C, Jones JP 3rd, Nasser AF (2016) Population Pharmacokinetic Modeling After Repeated Administrations of RBP-6000, a New, Subcutaneously Injectable, Long-Acting, Sustained-Release Formulation of Buprenorphine, for the Treatment of Opioid Use Disorder. J Clin Pharmacol., 56(7):806-815. http://dx.doi.org/10.1002/jcph.665
  6. Boscarino JA, Kirchner HL, Pitcavage JM, Nadipelli VR, Ronquest NA, Fitzpatrick MH, Han JJ (2016) Factors associated with opioid overdose: a 10-year retrospective study of patients in a large integrated health care system. Subst Abuse Rehabil. 7:131-141. http://dx.doi.org/10.2147/SAR.S108302
  7. Joshi A, Parris B, Liu Y, Heidbreder C, Gerk P, Halquist M (2017) Quantitative determination of buprenorphine, naloxone and their metabolites in rat plasma using hydrophilic interaction liquid chromatography coupled with tandem mass spectrometry. Biomed Chromatogr., 31(2). http://dx.doi.org/10.1002/bmc.3785
  8. Joshi A, Halquist M, Konsoula Z, Liu Y, Jones JP 3rd, Heidbreder C, Gerk PM (2017) Improving the oral bioavailability of buprenorphine: an in-vivo proof of concept. Pharm. Pharmacol., 69(1):23-31. http://dx.doi.org/10.1111/jphp.12652
  9. Ruetsch C, Tkacz J, Nadipelli, VR, Brady BL, Ronquest N, Un H, Volpicelli J (2017) Heterogeneity of Nonadherent Buprenorphine Patients: Subgroup Characteristics and Outcomes.  Am J Manag Care. 23(6):e172-e179. https://www.ncbi.nlm.nih.gov/pubmed/28817294
  10. Wollschlaeger BA, Willson TM, Montejano LB, Ronquest NA, Nadipelli, VR (2017) Characteristics and treatment patterns of US commercially insured and Medicaid patients with opioid dependence or abuse. J Opioid Manag. 13(4), 207-220. http://dx.doi.org/10.5055/jom.2017.0389