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.
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:
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:
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.
June 5, 2017
Additional details on the opioid epidemic are available in our FDA News article, entitled "Califf Pledges to Review FDA’s Opioid Policies to Address US Opioid Epidemic" In early February, Dr. Robert...
June 5, 2017
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
June 5, 2017
On Monday, August 6th, FDA released a new draft guidance on clinical endpoints for demonstrating effectiveness of drugs for medication-assisted treatment for opioid use disorder (OUD), entitled...