Zubsolv Phase 3 Clinical Trials – Positive Top-line Results Released
Uppsala, Sweden – June 23, 2014 – Orexo AB (publ) announces the results of two clinical trials assessing Zubsolv for induction of Buprenorphine maintenance therapy in patients with opioid dependence.
Nikolaj Sorensen, Chief Executive Officer of Orexo, noted “We know a main barrier for DATA2000 certified physicians to start treating opioid dependent patients, is perceived difficulties in the initiation phase of treatment. With an expanded label Orexo can take an active role to encourage and educate the certified, but not active, prescribers in initiation of treatment and improve access to treatment for patients suffering from opioid dependence”
A total of 1,068 opioid dependent patients, showed that over 90% of patients treated with Zubsolv were retained in treatment at Day 3 using a 30% . (emphasis added by author, this is impressive)
The full press-release for the clinical trials are here.
Zubsolv & Suboxone are chemically similar containing buprenorphine & naloxone
Zubsolv is the newest drug available for treatment of Opioid Dependence. The current leader-on-the-block for treatment of Opioid Dependence is Suboxone. Suboxone has been around for several years and is chemically similar to Zubsolv in that both medications consist of two drugs Buprenorphine and Naloxone.
What is Buprenorphine?
Buprenorphine is a narcotic analgesic, and it decreases pain by working in the brain and nervous system. Put simply, it is a habit-forming narcotic pain-killer in the same ballpark as other narcotic pain-killers such as Oxycodone or Hydrocodone. All narcotic pain-killers are capable of causing addiction problems and are likely to cause dependence problems with extended use.
What is Naloxone?
Naloxone prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension. Naloxone is an essentially pure opioid antagonist, i.e., it does not possess the “agonistic” or morphine-like properties characteristic of other opioid antagonists. When administered in usual doses and in the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.
Why do Zubsolv & Suboxone contain Buprenorphine & Naloxone?
The combination of buprenorphine and naloxone is what makes Zubsolv & Suboxone effective at treating opioid dependence. The buprenorphine alone would be like taking any other narcotic pain-medicine, however when mixed with Naloxone it makes abuse of the drug difficult if not impossible. The Naloxone displaces opiates so it prevents a dependent user from abusing the drug and getting intoxicated in a way that would lead to addiction. The Naloxone also makes using the drug in IV form not desirable. So the buprenorphine helps to remove the effects of withdrawal while the naloxone keeps the user honest and removes the ability to abuse the drug or use it in a way to get high.
I am generalizing here, but in my understanding this is the basic concept.
My Personal Experience With Zubsolv Compared To Suboxone
The results of the studies surprised me because I had an opportunity to try Zubsolv and it was my opinion that the Zubsolv 5.7mg was much less effective than the Suboxone 8mg strips. After making my opinion about Zubsolv I decided to share it via a Twitter post. I didn’t hold anything back when sharing my opinion, as you can see in the Tweet below.
First Tweet About Zubsolv:
I received a very polite response from Chris, he believed that my experience was likely due to the placebo effect and I pretty much discounted that theory immediately because my experience seemed real. When the same Twitter user replied again five days later, he informed me of a clinical study that was completed and was about to be released.
I am aware that placebo-effect is very real, and in light of the study I was willing to entertain the theory that my “mind mighthave been playing tricks on me”, but I was still pretty sure that I was right.
Responses from Twitter user @Christipojk
Bigger is always better, right?
After reading the full press release and results of the studies, it is my belief that placebo-effect really did cause me to believe Zubsolv was less effective than Suboxone and I suspect this will be common among other Suboxone loyalists. It is easy to fall for this belief considering that Zubsolv is a smaller dose, and in most peoples’ mind a smaller dose will not be as good as a larger one.
I am used to making one Suboxone 8mg strip last about a week by slicing it into eight equal parts, but when Suboxone wasn’t available and I had the opportunity to try Zubsolv I burned through 5.7mg tablets at the rate of one every three to four days– which was depressing as the medication is relatively expensive.
Micro-Doses of Zubsolv Are Challenging Considering The Small Tablet Size
Part of the problem with micro-doses of Zubsolv may be the difficulty in cutting the small Zubsolv tablets into small doses. Cutting a 5.7mg Zubsolv tablet (very small in size) into seven equal parts is close to impossible as the tablets are tiny and they crumble easily when you try to cut them. This alone may make Suboxone strips a better choice for some people.
Suboxone 8mg strips on the other-hand are very easily cut into eight, or even sixteen even parts using a razor blade or sharp scissors.
About Zubsolv®Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the maintenance treatment of opioid dependence and should be used as part of a comprehensive treatment plan, which includes counseling and psychosocial support. Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).
Zubsolv sublingual tablets can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential. Liver function tests should be monitored before and during treatment. Children who take Zubsolv sublingual tablets can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep Zubsolv sublingual tablets out of the sight and reach of children.