The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders.
At the pre-IND meeting, BioCorRx said it plans to win a nod from the FDA regarding its proposal to submit a new drug application under Section 505(b)(2). This type of approval pathway would allow BioCorRx to use previous safety and efficacy data collected by other groups to support its product.
“We are appreciative of the FDA’s response and look forward to meeting with them to present our plan for BICX101,” president & CEO Brady Granier said in prepared remarks. “Between now and the meeting date, we will continue to conduct more preclinical studies on BICX101 at Covance in order to collect additional data which will go into our briefing document to the FDA and IND filing. We continue to be excited about the potential for BICX101 to be utilized for multiple substance use disorder indications in the future.”
Also this week, FDA commissioner Dr. Scott Gottlieb urged his staff to consider “more forceful” efforts to curb the opioid epidemic that claims 91 lives in America every day, according to the Centers for Disease Control & Prevention.
“As commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction,” Gottlieb wrote in a blog post. “I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.”
Gottlieb established an Opioid Policy Steering Committee and posed to them 3 questions: Are there circumstances under which the FDA should mandate education for healthcare professionals regarding appropriate prescribing habits? Are there steps the FDA can take to ensure that opioid prescriptions reflect the clinical circumstances? Is the FDA adequately considering the risk of abuse and misuse as a part of the drug review and approval process?
“In the coming days, I’ll continue to work closely with the senior leadership of FDA,” Gottlieb wrote. “I want to know what other important ideas my colleagues at FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic.”