While the nation is still struggling to find the right strategy to climb out of the opioid crisis in U.S. it seems many are holding onto the idea that Big Pharma is going to save us from the destruction they helped create. While we can agree that evidence-based medical assistance in recovery is a useful tool, some seem to think that the only fix for a pill problem is more pills, or in this case, more needles.
Just recently, after President Trump declared the opioid crisis a “National Health Emergency”, the advisory committee to the U.S. Food and Drug Administration (FDA) voted 18-1 that a new injectable drug called RBP-6000 could benefit addicts and the lower of two doses studied had an “acceptable” safety profile.
So what does this mean for the opioid epidemic efforts? Is Indivior a miracle injection that is going to make the epidemic more manageable, or is it another kind of Methadone or Suboxone that is just keeping people hooked?
What is RBP-6000?
For a little background, RBP-6000 is an experimental drug designed to help fight America’s growing opioid addiction crisis. It is described as a sustained-release buprenorphine. It is designed to be delivered once a month as a subcutaneous injection. The compound solidified once in contact with bodily fluids and releases buprenorphine over time.
If approved, it will be the first monthly injectable buprenorphine treatment. When creating the drug the manufacturers studied two dosing regimens.
In one, 300 milligrams were given once a month for six months.
In the other, two doses of 300 milligrams were followed by four doses of 100 milligrams.
According to reports, there was only a minute difference in effectiveness between the two doses, and they drug company acknowledge that the higher dose of RBP-6000 caused more side effects. Looking closely into some of the reports from the research, some side-effects include:
Injection site pruritus
Upper respiratory tract infection
While these side effects were not noted in an extremely high percentage of those tested, they are still relevant to consider until there is more extensive data available. So far, the report says the safety profile is consistent with that of Suboxone.
So RBP-6000 is like Suboxone using the delivery of Vivitrol; another injectable drug used to try and block the effects of opioids.
Big Pharma Making Big Moves
This is one sign of how Big Pharma is stepping in to make a buck off of the opioid epidemic yet again.
Indivior is the company behind RBP-6000. It was originally part of Reckitt Benckiser as the Buprenorphine division but has since split off to be a specialty pharmaceutical company. Indivior already sells Suboxone Film, a product which combines buprenorphine and naloxone. Suboxone is a maintenance drug widely used in America to try and curb the effects of opioid addiction and withdrawal, but Suboxone is known to have its own side-effects and withdrawals. Some even attest that Suboxone is itself addictive and very difficult to get off of.
Two months ago the share prices for Indivior took a deep hit after a U.S. court ruling clearing the way for a generic rival to Suboxone Film. So, with new competition on the way in the Suboxone market, Indivior put a renewed focus on another maintenance drug to bring to market.
Some analysts already expect that RBP-6000 could capture around 30% of the broader buprenorphine market. Some believe this new form of injectable buprenorphine could generate annual sales of around $700 million by 2021.
Jefferies sees potential sales of $1.3 billion by 2025.
So now the push for this new drug is boosting its sales prospects as competitors threaten revenues from Suboxone sales.
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Waiting for FDA Final Ruling
This endorsement on behalf of RBP-6000 comes less than a week after FDA Commissioner Scott Gottlieb announced the agency’s plans to promote extensive use among opioid addicts of less harmful opioids such as methadone and buprenorphine, the active ingredient in RBP-6000.
However, some of the FDA panelists still would like to see more data about which patients should be given the higher dose. Other panelists say they would like to have it available, even though they lack of data supporting any additional benefit of higher doses. So even though the drug is shown to have side-effects in higher doses, and there is limited information on how these side-effects impact the individual, the FDA is considering to let this drug pass the grade.
The FDA’s decision is set to be made by November 30th, although typically the agency follows the recommendations of its advisory panels. So it may very well already be a done deal.
Why It Matters
Again, with respect to the importance of offering alternatives to particularly dangerous opioids like heroin or fentanyl. It is important to have resources for the purpose of preserving of life. Keeping people alive long enough to get help is crucial. But we also have to see that this is not a miracle cure.
Methadone, Suboxone, and Vivitrol may serve a purpose for some in a certain capacity. However, these drugs are not an adequate substitute for comprehensive addiction treatment. Each one of these methods should be accompanied by a holistic treatment plan that addresses all aspect of addiction, including emotional and mental health.
Drugs like RBP-6000 may help subdue the more serious symptoms from the physical side of addiction, but they can also present their own risks.
It is important to offer safe medical assistance, but we have to remember that these Big Pharma companies are not selling us instant cures to opioid addiction. This isn’t even the first time we have seen a new drug come out to try and treat the opioid problem from companies that are closely related or directly responsible for narcotic medications that helped fuel the issue.
Remember, there is not a quick fix for this problem. We cannot prescribe our way out of the problem. It is going to take better treatment resources beyond more medications.