Brixadi was approved by the FDA (U.S. Food and Drug Administration) on May 23, 2023, after about five years of clinical trials and formal applications to the FDA.
Before any drug can be approved, it undergoes a meticulously designed process to weigh its potential benefits against its risks. The FDA then decides if it’s safe and effective for patients.
Here’s how Braeburn, the manufacturing company, made this happen.
Brixadi – FDA Approval Process
Preclinical Research
Braeburn first had to provide laboratory and animal studies explaining Brixadi’s basic properties. These included its mechanism of action, how it’s supposed to interact with the body, and its preliminary safety profile.
The preclinical research phase was fairly short because buprenorphine, Brixadi’s active ingredient, has been FDA-approved since 1978. It was already a well-established drug, part of many medication-assisted treatment programs.
However, most buprenorphine-containing drugs came combined with naloxone in either oral form, such as pills or buccal films, or as an injection.
Brixadi, on the other hand, was the first and only long-acting buprenorphine injection available in multiple doses for weekly or monthly administration.
Investigational New Drug (IND) Application
The next step to FDA approval was submitting an IND (Investigational New Drug) application that explained Braeburn’s plan for testing Brixadi. They outlined the proposed clinical trials and set protocols for human testing.
Clinical Trials
Once the IND application was approved, Brixadi moved on to the clinical trials to test its efficiency in treating opioid dependence. This took place in three phases.
Phase 1
Brixadi was tested on a small group of healthy volunteers to observe its safety profile and pharmacokinetics, which means how the extended-release injection interacts with the body.
These individuals didn’t have opioid use disorder, nor did they need any kind of opioid treatment programs. They simply acted as a reference to see how the extended-release subcutaneous injection works.
This phase answered questions like, was Brixadi getting absorbed properly and reaching the bloodstream? How long did it take to start working, and how long did it last before the body eliminated it?
Braeburn was also able to test for potential side effects, which were few, except some injection-site irritation.
Phase 2
The second phase of clinical trials involved larger groups of people suffering from opioid withdrawal. The groups were divided into two, half taking Brixadi and the other half taking a placebo.
This phase proved Brixadi’s efficacy in treating opioid use disorder while exploring its safety profile and optimal dosing.
Phase 3
The final phase of trials included hundreds of participants from different locations, providing more diversity to the study results.
The individuals suffering from opioid dependency were divided into two groups once again, but this time, half was given Brixadi while the other half was given standard treatment.
The idea was to see how effective and safe Brixadi was compared to pre-existing opioid addiction medication.
At the end of phase three, clinical trials on Brixadi showed that it was just as reliable as other opioid addiction medications and even slightly more effective than some. These studies became the cornerstone of Braeburn’s application for FDA approval.
NDA (New Drug Application) Submission
After all these successful clinical trials, Braeburn submitted a comprehensive NDA (New Drug Application) to the FDA, including all the information and test results they had gathered.
They also added the manufacturing and labeling details they intended to use before releasing Brixadi to market.
FDA Review and Approval
Braeburn’s first application was met with a CRL (Complete Response Letter) from the FDA in December 2020. The FDA explained that they couldn’t approve the NDA because they found deficiencies while inspecting a third-party manufacturing facility.
This didn’t mean Brixadi’s efficiency or safety was flawed. It just meant that Braeburn needed to quickly address these manufacturing issues to get FDA approval, which they promptly did.
By November 2022, Braeburn had corrected the manufacturing issues and resubmitted the NDA.
In May of 2023, the FDA finally approved Brixadi for moderate to severe opioid use disorder after rigorously reviewing all of its safety, efficacy, and manufacturing data.
However, Brixadi would only be available through a REMS (Risk Evaluation and Mitigation Strategy) program. This means Brixadi can only be administered by certified healthcare providers in a healthcare setting.
Also, Brixadi would be part of a comprehensive treatment plan that included counseling and therapy, not a standalone treatment.
Access Medication-Assisted Treatment for Opioid Addiction Today…
Brixadi’s road to FDA approval was extensive and rigorous, but it opened up more treatment options for those battling opioid use disorder.
If you’re considering Brixadi on your recovery journey, book a consultation with Curednation’s telemedicine services, and let’s explore your options.
