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Buprenorphine Injectable for OUD on its Way

August 22, 2018
Braeburn's fast-tracked CAM2038 will offer weekly and monthly administration options for patients battling Opioid Use Disorder.

Pennsylvania-based biotech company Braeburn has a PDUFA target date of December 26, 2018 for its buprenorphine injectable aimed at treating opioid use disorder (OUD) in adults. FDA granted the product, dubbed CAM2038, Fast Track and Priority Review status in July 2015, and if approved at the end of this year, the investigational medication will be the first and only injectable available in both weekly and monthly options.

PPM spoke to CEO Mike Derkacz other potential benefits of the pipeline product.

PPM: How might a weekly or monthly buprenorphine dose improve upon current OUD options for patients?

Derkacz: According to the US Council of Economic Advisers, 58% of patients taking daily sublingual buprenorphine, which is the current standard of care for OUD, discontinue therapy within 30 days. We also know that patients with OUD who do not take at least 80% of their prescribed oral buprenorphine have over 10 times the risk of relapse than those who complete their prescribed course. There remains a need for an effective flexible-dose treatment option that can be individualized for patients with OUD.  Our goal is to support management of their disease and help mitigate the inherent risks of diversion and misuse associated with daily sublingual medication.

If approved, CAM2038 would be administered by healthcare providers (HCPs) through all stages of a patient’s recovery journey. Weekly and monthly formulations were developed to be customizable to match the HCP’s existing patient protocol and to be adjusted up or down based on the needs of individual patients, from initiation to longer-term maintenance therapy. The weekly formulation option also allows for more frequent interactions between patients and HCPs at a time early in treatment when the patient is most vulnerable. 

Additionally, as an HCP-administered weekly and monthly injectable treatment, CAM2038 could help to avoid the peaks and troughs typically associated with daily oral medications. Of note, in the CAM2038 clinical trials, patients were not required to complete a stabilization period on oral buprenorphine prior to starting on CAM2038.

 

PPM: How does CAM2038 compare to currently available medication-assisted treatment options in terms of side effects and reducing withdrawal symptoms?

Derkacz: In a pivotal Phase 3 trial, CAM2038 achieved the study’s primary endpoint, demonstrating non-inferiority compared to treatment with daily sublingual buprenorphine/naloxone (SL BPN/NX), the current standard of care. Further analysis of secondary outcomes demonstrated superiority (p=0.004) of CAM2038 to SL BPN/NX via Cumulative Distribution Function (CDF) test for the proportion of illicit opioid-negative urine samples during weeks 4 to 24.

The suppression of withdrawal throughout the study was comparable between the two treatment groups measured by mean (SD) Clinical Opiate Withdrawal Scale total score over time. Scores for both treatment groups were between 5 and 12 indicating mild withdrawal.  Additionally, cravings (measured by visual analog scale) were reduced in the CAM2038 treatment group as well as the SL BPN/NX group.

The overall safety profile of CAM2038 was consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events with CAM2038.

PPM: Why is Braeburn pursuing this area — medication-assisted treatment for OUD — of the pain management pipeline, in particular?

Derkacz: We recognize that there is a significant unmet need for patients suffering with OUD. We are committed to improving access to medication for the treatment of opioid use disorder by delivering next-generation therapies for patients living with OUD. Opioid addiction is the fastest growing public health crisis in America today and opioid overdose is the leading cause of death in people under the age of 50 – change is needed. 

Research shows that a combination of medication and psychosocial counseling can successfully treat OUD and help sustain long-term management of the disease. However, in 2016, roughly 11.6 million adults misused opioids in the US, according to the Substance Abuse and Mental Health Services Administration, yet only an estimated 1.1 million received MAT.

Braeburn developed CAM2038 because there remains a need for an effective weekly and monthly injectable treatment option that can be individualized for patients to support management of their disease – from initiation to long-term maintenance – and that can potentially help mitigate the potential risks of diversion and misuse associated with oral medication.

 

 

 

 

Last updated on: August 23, 2018
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