Illegal drugs such as heroin and certain prescription medications are continuing to cause major problems for people around the world. While most individuals think of illegal drugs when they hear the word ‘addiction’, others are suffering from devastating addictions to prescription drugs, and illnesses such as codeine addiction are becoming more common.
With many people unaware that taking prescription medications over an extended period of time dramatically increases their chances of developing a dependency on the drugs, it is no surprise that prescription medication addictions are a growing problem. Even those who do not misuse their prescription medication are at risk of developing addictions.
New Treatment Against Addiction
Officials at the US Food and Drug Administration are deciding whether to give their approval to a new implant that could become a new treatment for both opioid and heroin addiction. Braeburn Pharmaceuticals’ Probuphine Implant would provide a continuous dose of buprenorphine for six months when placed in the arm of a patient. The drug helps to prevent cravings and withdrawal symptoms that are synonymous with an opioid addiction.
Opioids are generally prescribed for chronic or severe pain and include codeine, oxycodone, methadone, and morphine. Heroin is an illegal opiate drug. In the US, there has been a two hundred per cent increase in the number of individuals who have died as a result of opioid overdose. However, it is not just in the US where opioid addictions have become a problem. Illnesses such as methadone, oxycodone and codeine addiction are common in the UK too.
With around two million people in the US struggling with addictions to opioid medications and a further half-a-million addicted to heroin, a new treatment is welcome news. At the moment, buprenorphine is only administered in pill form or as film that must be dissolved under the tongue. Nevertheless, these versions are commonly sold on the black market and there is also the risk of them being accidentally ingested by children.
The implant offers an innovative treatment in that it regulates the dose and there is minimal risk of anyone other than the intended patient getting hold of the medication.
According to Michael Sheehan, medical director at drug treatment provider Operation PAR, the implant would also make it more difficult for patients to stop taking their medication in order to get high, thus reducing the number of relapse cases. He said, “An implantable version that people don’t have a choice about taking out and stopping is a significant advance. I’ve been waiting for this medication for the last four years.”
All the signs point to the implant being approved by the FDA, which is good news on both sides of the Atlantic. Braeburn Pharmaceuticals’ chief executive Behshad Sheldon said that the company is cautiously optimistic about getting approval, considering they are currently finalising negotiations regarding the product label with the FDA. Ms Sheldon stated that this did not usually happen unless the product was going to be approved. Nonetheless, she added, “You know, nothing is ever 100 per cent.”
Clinical trials of the implant showed that eighty-six per cent of those who were given it stayed clean. Of those who used the buprenorphine film, seventy-two per cent remained drug-free.
In January 2016, an advisory panel to the FDA recommended that approval is given to the implant in a 12-5 vote. However, there are a number of critics of the implant, including the president of the National Centre for Health Research Diana Zuckerman, who is concerned about the safety of the implant. She believes that one short study cannot guarantee the safety and effectiveness of the drug. The only major study of the drug lasted just six months, and Ms Zuckerman said, “Opioid addiction is not a six-month problem. So you want to see what happens not only in the first six months but in the next six months.”
She said that during the trial, some participants required extra doses of buprenorphine film, which would suggest they were not benefitting from the implant. Nevertheless, in response, Braeburn said that eighty-two per cent of participants did not require extra doses of buprenorphine. Ms Zuckerman also pointed out that when participants missed scheduled urine tests, they were counted as ‘negative’ for illegal drugs. Braeburn contradicted this and said that participants who missed tests were actually classed as positive in terms of opioid use.
The National Centre for Health Research also had concerns regarding the effectiveness of the drug across ethnic groups because eighty-four per cent of those who took part in the trial were white. Nonetheless, president of the Segal Institute for Clinical Research, Dr Scott Segal, said that medications used to treat drug addiction generally did not differ among various races or ethnic groups. The Segal Institute was involved in testing the implants during the trial.
Michael Sheehan from Operation Par said that while some of the criticisms may be valid, they should not prevent the implant being approved, and added, “The implantable form is not for everybody. But certainly there are a number of people who would really appreciate it and benefit a lot from it being available.”
The implant could prove beneficial in the treatment of a number of addictions both in the US and here in the UK, including heroin, morphine and codeine addiction.
Source: The Orlando Sentinel