Pharmacodynamic and pharmacokinetic evaluation of buprenorphine + samidorphan for the treatment of major depressive disorder

ABSTRACT

Introduction: Treatment resistant depression (TRD) represents approximately 20% of all individuals receiving care for major depressive disorder. The opioidergic system is identified as a novel target which hitherto has not been sufficiently investigated in adults with TRD. The combination product buprenorphine + samidorphan is an opioid modulatory agent which has demonstrated replicated evidence of efficacy in TRD without abuse liability.

Areas covered: Databases Pubmed, Google Scholar and clinicaltrials.gov were searched from inception through December 2017 for clinical trial information, pharmacokinetics, and pharmacodynamics of buprenorphine + samidorphan. Herein we provide a summary of the available information. Eight clinical trials were identified for inclusion, of the eight trials, five trials had available results and are included in detail in our review.

Expert opinion: Buprenorphine + samidorphan has demonstrated efficacy in TRD. Extant evidence surrounding the safety and tolerability profile of buprenorphine + samidorphan does not identify any significant safety concerns. Additional studies are needed in order to assess the long-term safety and efficacy of this product.

KEYWORDS:

• Major depressive disorder
• buprenorphine + samidorphan
• opioidergic system
• treatment resistant depression
• opioid

Box 1. Drug summary.

Declaration of interest

Roger McIntyre has been on the advisory board/researcher, and received consulting fees and speaker fees from AstraZeneca; been on the advisory board/researcher, and received consulting fees and speaker fees from Bristol-Myers Squibb; has been on the advisory board/researcher, and received consulting fees and speaker fees from Eli Lilly; has been on the advisory board/researcher, and received consulting fees and speaker fees from Lundbeck; has been on the advisory board/researcher and received consulting fees and speaker fees from Pfizer; has been on the advisory board/researcher and received consulting fees and speaker fees from Merck; has been on the advisory board/researcher and received consulting fees and speaker fees from Sunovion; has been on the advisory board/researcher and received consulting fees and speaker fees from Otsuka; has been on the advisory board/researcher, and received consulting fees and speaker fees from Takeda; has been on the advisory board/researcher, and received consulting fees and speaker fees from Allergan; has been a researcher for and received speaker fees from Janssen-Ortho; and has completed research for and received funding for research from Shire. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. A reviewer on this manuscript has disclosed that they have received grants/research support, consulting fees and/or honoraria within the last three years from Angelini, AOP Orphan Pharmaceuticals AG, AstraZeneca, Eli Lilly, Janssen, KRKA-Pharma, Lundbeck, Neuraxpharm, Pfizer, Pierre Fabre, Schwabe and Servier.

A reviewer on this manuscript has disclosed that they have consulted and attended advisory boards for Alkermes.

Additional information

Funding

This paper was not funded