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- Propofen: a new drug for the treatment of opioid addiction
New Drug to Treat Addiction: According to the American Society of Addiction Medicine, approximately 2.6 million people had a substance use disorder involving opioids in 2015. Currently, drug overdose is the leading cause of death in the United States. The death rate from opioids has risen 400 percent since 1999.
Also obviously there is a huge problem in combating both substance use disorders and overdoses involving opioids. Fortunately, with a new drug on the market available to the public as of June 21, Probuphine might be the answer you’re looking for.
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What is propofen? (a new drug to treat addiction)
Probufen is an implant that provides a fixed dose of buprenorphine for people with opioid use disorders. Four of the 1-inch rods comprising the implant are inserted into the inner part of the upper arm by a trained physician during an outpatient visit, lasting six months.
It’s the first implant approved by the U.S. Food and Drug Administration to treat opioid addiction, but buprenorphine itself is not a new drug; It’s been approved to treat opioid addiction since October 2002. Buprenorphine is a partial opioid agonist, which means it acts on the same receptors in the brain as opioids, but does not produce the same elevated or side effects. In addition, it creates a “ceiling effect”, so that you do not yearn to rise to the same maximum.
What is its history?
Probuphine has been in development since 2007-2008 when two studies – 805 and 807 – were conducted in 2009, the implant applicator and removal clips were redesigned, removal technique changed, and training consisting of a manual, video, half-day lesson and workshop was developed Practical training In 2010 and 2011, studies 806 and 811 were conducted, and in 2014, the final study (814) was completed. These studies were conducted by Titan Pharmaceuticals.
Clinical trials of Probuphine were conducted from 2007 to 2015 and consisted of three phases:
Phase I compared urine tests of people who had propofen implants with those of people who had propofene implants. This phase found that an average of 40.4 percent of people who had a buprenorphine implant had negative results on opioids versus 28.3 percent of people who took a placebo.
Phase II compared buprenorphine implants with sham implants and buprenorphine/naloxone tablets. This phase found that propofen was significantly more effective than placebo, but its effects were similar to those of the tablets.
Phase III compared two groups of patients stable on 8 mg or less of buprenorphine/naloxone tablets. One group received a placebo implant and continued using the regular tablets, while the other group received Probuphine implants and placebo tablets This phase found that 88 percent of those treated with Probufen showed negative results for opioid use during the six-month study, compared with 72 in 100 of those who took buprenorphine/naloxone tablets
So Probuphine was approved by the FDA on May 26, 2016 Braeburn Pharmaceuticals (a Probuphine license holder) had the ability to train three thousand doctors how to insert Probuphine bars in the next six weeks By May 27, 2016, 2,250 had been registered already supplied. Within a month, that number had risen to around four thousand and Brayburn recognized his coaching abilities for 2016.
Probufen is the first implant approved by the US Food and Drug Administration to treat opioid addiction, but buprenorphine itself is not a new drug; It’s been approved for the treatment of opioid dependence since October 2002. Buprenorphine is a partial opioid agonist, which means it acts on the same receptors in the brain as opioids, but does not produce the same elevated or side effects. In addition, it creates a “ceiling effect”, so that people who use it do not crave its effects to the same maximum.
Who should use it?
Probufen is indicated for people who:
dependent on opiates
She was stable on buprenorphine across the mucosa (dissolved film between the cheek and gum) for a long period of time
Take a low to moderate dose (no more than 8 mg per day) of buprenorphine
What are the benefits? (A new drug for addiction treatment)
Some of the benefits of Probuphine include:
Low rates of illicit opioid use. In a six-month clinical trial, sublingual buprenorphine and buprenorphine were compared with each other. Probufen has always been on the front line, with more than 90 percent of cumulative negative opioid use in months 1-5 and more than 80 percent of cumulative negative opioid use at six months. In comparison, sublingual buprenorphine decreased from more than 90 percent in the first month to more than 70 percent in the sixth month.
Make sure to take the medication as prescribed. According to the Centers for Disease Control and Prevention, only about half of people take their medication as prescribed, 20-30 percent never fill their prescriptions, and an unknown amount forget to take their medication or decide not to. If someone with an opioid use disorder falls down the buprenorphine pathway and then uses opioids, they could easily overdose and die. This scenario currently contributes to high rates of overdose, according to the National Institute on Drug Abuse.
Follow Some of the benefits of Probuphine include:
Make sure that people cannot use buprenorphine for altitude. Because buprenorphine is an opiate, it can be abused to get high. The Probuphine implant regulates the amount of buprenorphine a person receives per day and has strict guidelines so that it cannot be abused. Furthermore, the trans-mucosal form of buprenorphine can be given away or sold for illicit purposes, while the implant cannot.
Eliminate dangers to children. Children may confuse other forms of buprenorphine with candy and may experience drowsiness, vomiting, slow breathing, fast heartbeat, agitation, coma, and death.
Access to discreet homes and halfway houses. These facilities have generally not taken people taking medication yet to avoid the risk of illicit use of the substances. Because Probuphine is an implant, this risk is mitigated.
Enhance your privacy. Many people with substance use disorders want this information to remain confidential due to fear of stigma. Without having to take buprenorphine daily or fill a prescription every month, you can embark on your recovery without worrying about judgment.
Are there side effects or risks?
Also, there are some harmful side effects that come with propofen. Among people who use the drug, 13 percent feel pain at the implant site, 12 percent get redness at the implant site and 13 percent have headaches Less than 10 percent of people have who use propofen for back pain, constipation, depression, headache, nausea, oropharyngeal pain (ie the base of the tongue, soft palate, tonsils, back and side wall of the throat), dental pain and vomiting.
Other risks include:
Fetal harm and neonatal withdrawal syndrome (if used during pregnancy)
transplant expulsion
Implant protrusion
transplant migration
infection
Nerve damage caused by insertion
Also to combat these risks, all physicians must be trained in the Probuphine REMS (Risk Assessment and Mitigation Strategy) program, which involves conducting implant training, a live insertion and removal procedure and a practical d certification exam that must be renewed annually. Before receiving REMS training, the provider must also have performed an eligible surgery in the past three months.
You can also reduce your risk by not trying to remove the implants yourself. This can lead to infection or immediate withdrawal symptoms. If the implants come out on their own, follow these instructions:
Wash your hands if you have touched the implants and do not allow anyone else to touch them
Cover the area with a clea n . bandage
Without touching the implants directly, put them in a plastic bag and keep them in a safe place away from children
Take the implants to your doctor as soon as possible
Should I continue with other treatments?
Just because you don’t have to go to the doctor often to refill your buprenorphine prescription doesn’t mean you shouldn’t also undergo complementary therapy. The prescribing information for Probufen provided by the U.S. Food and Drug Administration states that it should only be used in conjunction with counseling and other support, including rehabilitation, therapy, and 12-step programs.
Remember that propofen is a medicine like any other medicine and should be handled in this way. It could be one of the many tools on the road to recovery.
Sources: Arlotta, CJ. The first buprenorphine implant approved by the FDA for opioid dependence. Pharma and healthcare. Forbes, May 27, 2016. December 21, 2016. Bibinger, Martha. The new addiction treatment implant will hit the market next month, priced at $4,950. CommonHealth. WBUR, May 27, 2016. December 21, 2016.” buprenorphine; “Drug Abuse/Related Topics”. National Institute on Drug Abuse. December 21, 2016.” List of recommended medications.
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Also HealthNet Medi-Cal, 2016. December 21, 2016. Lee, MD, Desiree & Brooks, Megan. Buprenorphine, collaborative care key to successful treatment of opioid dependence. “Medscape Education Clinical Abstracts”. Medscape, March 28, 2011. December 21, 2016. Ling, W.; , and others. the. Buprenorphine implants for the treatment of opioid dependence: a randomized controlled trial. Journal of the American Medical Association. National Center for Biotechnology Information, October 13, 2010. December 22, 2016. Mangan, Dan. FDA approves first implant to treat opioid addiction. ” Healthcare. CNBC, May 26, 2016. December 21, 2016. “Opioid Addiction 2016 Facts and Figures.” “American Society of Addiction Medicine, 2016. December 21, 2016.” Oral cavity and pharynx cancer.” Learn about cancer. American Cancer Society, January 27, 2016. December 22, 2016. Pedecord, Sarah. FDA approves first buprenorphine implant to treat opioid dependence. ” News and Events. U.S. Food and Drug Administration, May 26, 2016. December 21, 2016. Description information. “Brayborn Pharmaceuticals”. U.S. Food and Drug Administration, May 26, 2016. December 21, 2016. propofene; “Brayborn Pharmaceuticals”.
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Also US Food and Drug Administration, January 12, 2016 December 21, 2016. Probuphine Implant (Buprenorphine) Pharmaceutical Coverage Policy. Humana, September 21, 2016. December 21, 2016. Ramsey, Lydia. This tiny implant has just been approved to tackle the heroin epidemic in America. ” Science. Business Insider, May 26, 2016. December 21, 2016. Reed, RN, BSN, Mead, Nicole. Buprenorphine: Dangerous for children. “Information on Poisons and Prevention. National Capital Poison Control Center, 2016. December 22, 2016. Rosenthal, RN, et al. the. Buprenorphine implants for the treatment of opioid dependence: a randomized comparison with placebo and sublingual buprenorphine/naloxone. ” addicted. National Center for Biotechnology Information, December 2013. December 22, 2016. Smith, Tyler. “Help with opioid addiction at UCSD may be more than skin deep. ” News.
Also University of Colorado Health, August 17, 2016 December 21, 2016. Table 36: Agents of Quitting Drug and Alcohol Abuse “Official Website of the Executive Office of Health and Human Services (EOHHS) Massachusetts, October 2016. December 21, 2016.” Titan Pharmaceuticals Reports Positive Phase 3 Propofine Phase 3 Opioid Addiction. Press statements. Titan Pharmaceuticals, June 8, 2015. December 22, 2016. “What should I do after insertion of Proprofen implants? ” Patients. Propofen Program for Risk Assessment and Mitigation. December 21, 2016.
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Recovery Village aims to improve the quality of life for people with substance abuse or mental health disorders through fact-based content about the nature of behavioral health conditions, treatment options, and related outcomes We publish materials that are researched, cited, edited, and reviewed by licensed medical professionals. The information we provide is not intended as a substitute for professional medical advice, diagnosis or treatment. It should not be used in place of the advice of your doctor or other qualified healthcare provider.
