A new implant known as ‘probuphine’ is being hailed as a potential cure for opiate addiction. This includes addiction to heroin, methadone and other opiate-based painkillers such as OxyContin, oxycodone and tramadol.
Probuphine was this week approved by the US Food and Drug Administrator (FDA).
The drug contains two drugs that are capable of reversing the effects of opiates such as heroin and methadone. These two drugs have been identified as buprenorphine and naloxone.
Patients receive probuphine implants which slowly secrete these drugs into the blood over a six month period. These drugs then work by ‘counteracting’ the effects that opiates have on the body, particularly the brain.
Over time patients who receive this implant will no longer experience cravings when heroin or other opiates are withdrawn.
The drug is produced by New Jersey-based Braeburn Pharmaceuticals.
The company’s CEO, Behshad Sheldon, said: “More long-term treatments are needed to help people stay in recovery, and we remain excited about the potential for probuphine to be the first of many new options for people with opioid addiction.”
The implant is surgically attached to patients under the skin of the upper arm. Once treatment concludes, the implant is removed.
The implant works by providing the addict with a ‘steady’ supply of buprenorphine. Buprenorphine is itself a non-illicit and synthetic opiate that’s specifically designed to treat opiate addiction. Buprenorphine treats opiate addiction by reducing withdrawal symptoms, particularly cravings for drugs such as heroin when a reduction programme is attempted.
Before buprenorphine was only available in pill form. This made it easy for addicts to neglect their buprenorphine treatment. In some cases, addicts even sold buprenorphine in order to raise the necessary funds to purchase heroin. Implanted buprenorphine thus overcomes this key disadvantage of the tablet form of the drug.
Buprenorphine is considered superior to other opiate substitutes such as methadone. This is because users are less likely to overdose and die when on buprenorphine. Overdose is a particular disadvantage of a methadone-based reduction programme.
The effectiveness of probuphine was tested during a clinical trial taking place in January 2014. 178 addicts took part. All of these addicts had since failed to give up opiates after receiving treatment involving naloxone, suboxone or buprenorphine.
By July 2014, 88% of the trial’s participants tested negative for illicit opiates. A ‘control group’ was also given buprenorphine in tablet form. 72% of participants given buprenorphine in tablet form tested negative for illicit opiates six months after the trial had begun.
Experts now estimate over two million Americans currently suffer from some form of opiate addiction. Over two hundred thousand Americans are believed to suffer from an addiction to ‘street’ heroin.
The vast majority of opiate addicts in America are addicted to ‘non-illicit’ opiates such as codeine, oxycodone and hydromorphone. Non-illicit opiates are thought to contribute to the lion’s share of America’s 47,055 opiate-related deaths in 2014.
The FDA is expected to initially roll out probuphine implants only to ‘stable’ patients who have already demonstrated a commitment to buprenorphine treatment using tablets.
It is unclear how heroin rehab centres will work with this treatment.
Some criticised the FDA for granting probuphine’s approval. Experts claim the drug’s manufacturer, Braeburn Pharmaceuticals, should have been required to carry out multiple clinical trials proving the drug’s effectiveness. In reality, only one such trial was carried out. This single trial also contained a number of flaws. For instance, patients who missed urine tests were counted as ‘negative’ i.e., that no drug was present in their system. This is despite evidence suggesting patients avoid urine tests in order to conceal their drug use.
Pharmacist Tracy Rupp said “Is probuphine effective? We still don’t know because the study was poorly designed and missing data. Many people who are addicted to opiates need to take medication for years. The current trial this approval is based contained many failings and only tracked patients progress for too short a period.”