As the opioid epidemic raged on in the US, there was increased pressure for scientists to work on a form of extended-release naltrexone which would help people with an addiction to opioid-containing medicines, opioid street drugs, and alcohol.
But how much do you know about the medication’s history and who makes it?
In this article, we will answer this common question. We will explain how the medication was made to help people with opioid use disorder for the treatment of alcohol dependence, as well as who is behind the injectable medicine.
Read on to learn more about:
- The Manufacturer of Vivitrol
- The Development and Approval of Vivitrol
- How Vivitrol Is Used
- The Benefits Of Vivitrol
- What You Should Know: Side Effects and Risks
Let’s get into it.
The Manufacturer of Vivitrol
Vivitrol is manufactured by the Irish company Alkermes, Inc. The company specializes in making medications for psychiatric and neurological disorders.
The company is also known for developing long-acting injectable versions of medications, such as Vivitrol.
Vivitrol is the injectable version of naltrexone, which acts to block the effects of opioids. It is given as part of medication-assisted treatment for opioid dependence and alcohol addiction.
Naltrexone has long been used for the treatment of opioid dependence before the development of the monthly injection, now called Vivitrol.
The Development and Approval of Vivitrol
The opioid crisis saw an astronomical amount of people become addicted to opioid pain medication, along with opioid street drugs.
Many people became addicted to opioid-containing medicines due to overprescription, which often put people at risk of opioid overdose.
This exerted pressure on pharmaceutical companies to create safe and effective treatments for opioid use disorder in order to help people who suffered from opioid addiction in their recovery.
- Development: Naltrexone, the active ingredient was developed and approved by the FDA for the treatment of alcohol use disorder in 1984. Research was then conducted into how the medication could be formulated into an injectable form, which could be given just once a month
- Clinical Trials: Once the medication was made into an injectable form, it was then put through rigorous testing including clinical trials. This involved testing the medication on healthy volunteers, followed by other clinical trials that looked at the optimal dosing in patients with alcohol or opioid dependence
- Regulatory Approval: After completing various tests as well as clinical trials, Alkermes, the manufacturer of Vivitrol the findings to the U.S. Food and Drug Administration (FDA) reviewed the safety and efficacy of the medication
- FDA Review and Approval: The FDA reviewed the findings of the studies looking at the risks and benefits of Vivitrol, and eventually approved the medication for the treatment of alcohol dependence in 2006 and then for the prevention of relapse to opioid dependence in 2010.
How Vivitrol Is Used
Vivitrol, also known as extended-release naltrexone, is a prescription-only medication that is used as part of Medication-Assisted treatment.
It is given to people who have undergone opioid detoxification and is designed to reduce their risk of relapse, during recovery.
Vivitrol can also be prescribed to people who suffer from alcohol dependency to reduce alcohol cravings.
The medication is given as an intramuscular injection to people with opioid addiction and alcoholism once a month in a clinic.
The opioid blockade lasts for the whole month and is often used with behavioral theories as part of drug recovery programs.
The Benefits Of Vivitrol
- Reduced cravings for opioids or alcohol: Vivitrol uses Naltrexone, which is designed to block opioid receptors in the brain. This makes the experience of opioids and alcohol less rewarding to the brain which helps to control drug cravings
- Helps prevent relapse: Clinical trials have shown that Vivitrol formulation helps to lower opioid relapse rates, as well as help people who suffer from alcoholism to maintain sobriety for longer. The medication is therefore often prescribed with therapy and other interventions to help support people through recovery
- Non-Addictive: Unlike other opioid replacement therapies that activate the opioid receptors, Vivitrol blocks the receptors, which means it is considered as being non-addictive
- Increased Compliance: Because Vivitrol is given to people after opioid detoxification as a monthly injection, its effects last for about 4 weeks. There is no need to take daily medications, making it easy to remember and reducing the risk of relapse in people with an opioid addiction
- Minimal Severe Reactions: Due to the extensive research and approval by the FDA, the medication is deemed safe, and serious adverse effects such as severe injection site reactions are rare.
What You Should Know: Side Effects and Risks
While Vivitrol can help people who have a dependence on opioids and alcohol maintain their assistance, there are some common side effects that you should be aware of.
Common side effects include:
- Cold symptoms including a runny nose
- Nausea
- Headaches
- Sleep problems
- Allergic reactions
- Muscle cramps and muscle aches
- Joint pain
- Signs of liver damage
- Sudden opioid withdrawal symptoms in people who have not fully detoxified
- Injection site reactions.
People who have also been taking the medications for longer periods are also at risk of overdose due to their increased sensitivity to opioids.
After a period of time, people’s normal doses of opioids may be dangerous due to their reduced tolerance to opioids, putting them at risk of fatal overdose.
People who also try to take large amounts of opioids to overcome the opioid blockade are also at risk of overdose.
Conclusion
Vivitrol is a medication that was developed by the Irish drug company, Alkermes. The medication was made and tested in many clinical studies which looked at the safety and efficacy of the medication.
Vivitrol was first approved by the FDA in 2006 for use in people with alcohol dependency. It was then again approved by the FDA for use in people with Opioid Use Disorder in 2010.
Since then, Vivitrol has been widely used in people who suffer from substance abuse to help them maintain their sobriety from opioid drugs as well as alcohol.
If you are considering the medication, it is useful to talk to your healthcare provider about how Vivitrol could help you.
