BioCorRx announced today that it submitted to the FDA an expanded access program application for its BICX104 implantable naltrexone pellet.
BICX104, a biodegradable implantable pellet, treats opioid use disorder (OUD). The expanded access program would enable the treatment to reach eligible patients before full FDA approval.
The FDA program provides access to products before approval for those with a serious or immediately life-threatening disease. It also applies to people with a condition where standard treatment options have been exhausted or are unsuitable.
BioCorRx already submitted a fast track application to the FDA last month. With the expanded access filing, it hopes to get its clinical trials promptly completed and obtain full FDA approval while helping OUD patients now.
The implantable pellet demonstrated a favorable safety profile in the company’s study’s, President and CEO Brady Granier said in a news release. It also delivered therapeutic levels of naltrexone over 84 days — three times the duration of the currently marketed 28-day injection.
BioCorRx said that, per FDA guidance, it expects to learn of the decision on its expanded access application within 30 days. In the meantime, the company intends to continue working on its new drug application for full FDA marketing approval.
“We chose to submit this expanded access treatment protocol to bring the benefits of our safe, effective, and potentially life-saving naltrexone implant to patients suffering with OUD,” Granier said. “Our Phase I clinical trial results encouraged us to apply to the FDA to get our BICX104 treatment to the public as soon as possible. If our expanded access application is approved, we look forward to implementing our program to promote the distribution of BICX104 to OUD patients through qualified healthcare providers.”