US-based Braeburn Pharmaceuticals and Swedish biotechnology firm Camurus have reported positive top line results from a multiple-dose, pivotal Phase II trial, evaluating the blockade by CAM2038 of subjective opioid effects of multiple, randomised, hydromorphone challenges in adults with opioid use disorder.
It is reported that a key objective of medication-assisted treatment for opioid use disorder is to reduce or eliminate the use of illicit opioids.
The results show that CAM2038 effectively blocks the subjective effects of opioid challenges with hydromorphone, including limiting drug liking.
The three-centre, randomised, double-blind, inpatient Phase II trial evaluated the degree of subjective opioid blocking efficacy of CAM2038 q1w in non-treatment-seeking participants with moderate-to-severe opioid use disorder.
Upon screening, participants were randomised to different CAM2038 q1w once-weekly injections for two weeks.
The company noted that during this period, four challenge sessions were conducted with a randomised hydromorphone dose to determine subjective ‘liking’ score based on a visual analogue scale.
It is reported that the primary endpoint of the trial was met for both CAM2038 doses, showing blockade of the subjective effects of hydromorphone as measured by the Drug Liking Visual Analog Scale.
In addition, CAM2038 was well tolerated across the course of treatment.
Braeburn Pharmaceuticals president and CEO Behshad Sheldon said: "This study provides clinical proof of concept that CAM2038 will be an effective treatment for opioid use disorder.
"The current opioid crisis demands innovation, and CAM2038’s novel technology is now one step closer to providing physicians and patients with a different approach to treating this deadly chronic disease."
The investigational CAM2038 buprenorphine subcutaneous injection products to treat opioid use disorder are being developed as once-weekly and once-monthly formulations, each with multiple doses, to cover all phases of treatment from initiation through maintenance.
The CAM2038 products are designed for administration by healthcare personnel to ensure proper delivery that reduces the risks of diversion, abuse, misuse and accidental exposure.
These products have been evaluated in three Phase I/II clinical trials, which evaluated the safety and tolerability, as well as pharmacokinetic and pharmacodynamic properties of the products in a total of 176 individuals.
Camurus president and CEO Fredrik Tiberg said: "The study results show that CAM2038 provides rapid and extended blockade of opioid effects.
"The results also confirm the dose selection in the current Phase III programme and the potential of CAM2038 as a future treatment alternative for patients with opioid use disorder, from initiation to long-term maintenance."