US Opioid Epidemic: NDA for Drug to Treat Opioid Use Disorder Submitted to FDA

June 5, 2017

On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat moderate-to-severe cases of Opioid Use Disorder (OUD).  The drug, RBP-6000, is a once-monthly injectable buprenorphine, and is intended to be part of a complete treatment plan in combination with counseling and psychosocial support.

What is OUD?

OUD is a substance abuse disorder characterized by compulsive self-administration of opioids that occurs for a prolonged period of time, and for no legitimate purpose.  OUD can also occur in patients suffering from a medical condition that requires the use of opioids.  In these cases, the patient would be considered to suffer from OUD if the opioids are used in doses significantly exceeding the amount needed and prescribed for the treatment of that medical condition.

Indivior’s recent press release provides a number of eye-opening facts regarding the use and abuse of opioids in the US, including:

  • In the past month, approximately 4.3 million Americans engaged in non-medical use of painkillers including opioids.
  • In the past year:
    • “1.9 million Americans met criteria for prescription painkillers use disorder based on their use of prescription painkillers.”
    • “1.4 million people used prescription painkillers non-medically for the first time.”
    • “4.8 million people have used heroin at some point in their lives with 212,000 people aged 12 or older using heroin for the first time.”
  • Between 2001 and 2014:
    • “Deaths from overdose of opioid analgesics (including opioids, methadone and other synthetic narcotics) showed a 4.7-fold increase from 5,528 to 18,893 deaths.”
    • “Heroin-related overdose fatalities showed a 5.4-fold increase,” growing from 1,779 deaths in 2001 to 10,574 in 2014.


RBP-6000 is a sustained-release product that uses Indivior’s ATRIGEL® delivery system.  This “consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent.”  After the drug is injected subcutaneously, “NMP diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.”

Prior to submission of its NDA, Indivior completed a pivotal Phase 3 study, which spanned a six-month duration.  This study assessed the safety and efficacy of the product, which the company states met both the primary and secondary endpoints.  During this study, the most common adverse events reported include:

  • Headache
  • Constipation
  • Nausea
  • Injection site pruritus
  • Vomiting
  • Insomnia
  • Upper respiratory tract infection

However, Indivior points out that, although these were the most commonly experienced side effects, they were reported by less than five percent of study participants.

For additional information on the NDA submission or the product itself, view Indivior’s recent press release.

Our team of regulatory affairs experts specialize in all things pertaining to FDA submissions and can help get your product approved by the Agency in the most time and cost effective manner.  To learn more about our services, contact us today.


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