CAM-2038, a new liquid-lipid crystal depot buprenorphine: a dose-ranging suite of weekly and monthly subcutaneous depot injections

First published: 13/03/2019 | Last updated: March 28th, 2019

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Dr Fredrik Tiberg

President & CEO

PhD, Assoc. Prof.

Fredrik Tiberg serves as President & CEO of Camurus since 2003. Camurus is a Swedish research-based pharmaceutical company committed to the development of innovative medicines for chronic and severe diseases.

Dr. Tiberg received his MSc (Chemical Engineering) from Lund Institute of Technology, and his PhD in Physical Chemistry from Lund University. He was appointed Professor in Physical Chemistry at Lund University in 1999, a position he held until 2017. During 2001-2002 he was Visiting Professor at the Physical and Theoretical Chemistry Laboratory, Oxford University. His research interests span from biophysical chemistry and advanced materials to clinical research.

He has published more than 100 original scientific papers, co-authored several books, and is named inventor on more than 300 issued patents. Fredrik is a member of the Royal Swedish Academy of Engineering Sciences (IVA).



CAM2038 are investigational weekly and monthly buprenorphine depots under regulatory review in the EU, Australia and the US for the treatment of opioid dependence. Formulated with the FluidCrystal® technology [1], CAM2038 is presented ready for use in a pre-filled syringe for administration as a small dose volume (0.16-0.64 mL) subcutaneous injection. Administration by healthcare professionals increases medication adherence, while potentially reducing risks of diversion, misuse, and accidental exposure to children.

CAM2038 has been evaluated in a comprehensive clinical development program with four Phase 1-2 pharmacokinetic studies, one Phase 2 proof-of-concept opioid challenge study, and two Phase 3 clinical efficacy and long-term safety studies. Results from these studies show that CAM2038 provides dose-proportional and long-acting buprenorphine release suited for weekly and monthly dosing, rapid and sustained suppression of opioid cravings and withdrawal, and complete blockade of opioid drug-liking from the first dose [2, 3, 4]. In the pivotal double-blind comparative Phase 3 study against daily medication with sublingual buprenorphine/naloxone, CAM2038 met both non-inferiority and superiority endpoints [5]. The safety profile showed no unexpected adverse findings.

These and other treatment-related outcomes will be discussed and related to product properties and dosing regimens.

 

References:

[1] Tiberg F, Johnnson M, Jankunec M, et al. Phase behavior, functions, and medical applications of soy phosphatidylcholine and diglyceride lipid compositions. Chem Lett. 2012;41:1090-1092.

[2] Albayaty M, Linden M, Olsson H, et al. Pharmacokinetic Evaluation of Once-Weekly and Once-Monthly Buprenorphine Subcutaneous Injection Depots (CAM2038) Versus Intravenous and Sublingual Buprenorphine in Healthy Volunteers Under Naltrexone Blockade: An Open-Label Phase 1 Study. Adv Ther. 2017;34:560-575.

[3] Haasen C, Linden M, Tiberg F. Pharmacokinetics and pharmacodynamics of a buprenorphine subcutaneous depot formulation (CAM2038) for once-weekly dosing in patients with opioid use disorder. J Subst Abuse Treat. 2017;78:22-29.

[4] Walsh SL, Comer SD, Lofwall MR, et al. Effect of buprenorphine weekly depot (CAM2038) and hydromorphone blockade in individuals with opioid use disorder: A randomized clinical trial. JAMA Psychiatry 2017;74:894-902.

[5] Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial. JAMA Intern Med. 2018;178:764-773.

 

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Dr Fredrik Tiberg


 

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