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news.Braeburn Pharmaceuticals and Camurus have enrolled the first patient in a phase 3 clinical trial of CAM2038, long-acting subcutaneous buprenorphine injections to treat opioid dependence.
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The study, which will evaluate the safety and clinical efficacy of CAM2038 weekly and monthly injections, is a part of the pivotal registration program for which the companies received guidance from both US Food and Drug Administration and the European Medical Agency.
It includes both new entrants who are actively seeking treatment, and patients presently receiving maintenance treatment with sublingual buprenorphine.
The treatment to new entrants will be started with the CAM2038 weekly product. The companies can make dose adjustments and switching between the weekly and monthly products.
The investigational CAM2038 buprenorphine subcutaneous injection products for treatment of opioid addiction are being developed as once-weekly and once-monthly formulations.
Each formulation will have several doses, covering all phases of treatment from initiation through maintenance.
Braeburn and Camurus have already evaluated the safety and tolerability of the CAM2038 products in three phase 1/2 clinical studies.
Pharmacokinetic and pharmacodynamic properties of the products were also evaluated in a total of 176 individuals.
Camurus president and CEO Fredrik Tiberg said: "Starting enrollment of patients in this global Phase 3 trial represents a key milestone in the development of our long-acting buprenorphine products.
"Along with the recently started Phase 2 opioid blockade study and a second Phase 3 trial under initiation, it forms the basis for forthcoming regulatory submissions."