Invidior approaches FDA Approval of Opioid Addiction Treatment

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Invidior has revamped buprenorphine with a sustained release formulation known as RBP-6000 that shows promising results in Phase III clinical trials for the treatment of opioid addiction.

logoThe latest addiction treatment from Invidior, RBP-6000, has made considerable progress through Phase III clinical trials. At the core of RBP-6000 is the old drug, buprenorphine, but Invidior has leveraged its ATRIGEL® delivery system to chaperone its release over a month-long period.

RBP-6000 operates similarly to a nicotine patch: buprenorphine is stored in a biodegradable polymer matrix injected subcutaneously and slowly diffuses from the cluster. This process is controlled by N-methyl pyrrolidone (NMP), a co-polymer that traps buprenorphine but degrades over time, releasing the drug into the bloodstream.

The Food and Drug Administration of the United States granted RBP-6000 fast-track designation to address the ever-growing opioid abuse and addiction epidemic. Beyond the well-known horrors of life with opioid addiction, researchers at Princeton University estimate that opioids have resulted in half a million deaths between 1999 and 2013.1 Research on therapies for addiction have recently accelerated, and through RBP-6000, Invidior aims to address the challenges of consistent treatment and relapse.

Fig. 1. Heroin has been used for centuries; these days, it is mostly taken intravenously. However, its cousin, oxycodone, is the most prominent contributor to the opioid epidemic.

“RBP-6000 was designed to offer physicians the potential for increased certainty of treatment adherence, and developed with the desire to help mitigate abuse, misuse, and diversion of medication,” said Shaun Thaxter, Chief Executive Officer of Indivior.

Indeed, patients taking RBP-6000 demonstrated minimal signs of further opioid abuse in their self-reports and urine samples. The drug will be marketed as a prescription sublingual film that should be paired with the psychosocial therapy. The next steps for Invidior will be further data analysis of the treatment’s long-term safety and tolerability; with this confirmed, Invidior aims to apply for FDA approval in the first quarter of 2017.

Since the news of RBP-6000’s progress was announced, the stock price of Invidior has increased by 17%, jumping from 3.49€ to 3.83€. The company claims to manage the largest pipeline in the world for addiction drugs and has developed other products for alcohol dependence and cocaine and opioid overdose.

We believe that RBP-6000 can potentially transform the treatment of opioid dependence.” Shaun Thaxter, CEO, Indivior

(1) Anne Case and Angus Deaton . “Rising morbidity and mortality in midlife among white non-Hispanic Americans in the 21st century.” Proceedings of the National Academy of Sciences. vol. 112, no. 49. December 8, 2015. 15078–15083.
Featured Image: Pills (CC 2.0, Me/Flickr)
Figure 1: drugs (CC 2.0, Dimitris Kalogeropoylos/Flickr)


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