FDA Set to Make Decision on Opioid Implant Treatment
The U.S. Food and Drug Administration (FDA) will make a decision on May 27 whether to approve the Probuphine implant created by Braeburn Pharmaceuticals to treat opioid addiction.
In January, an advisory panel of experts approved the use of the Probuphine device in a 12-5 vote and sent their recommendations to the FDA chiefs.
Probuphine Implant for Opioid Addiction Treatment
Probuphine implants are four matchstick-size rods inserted under the skin of the upper arm from where they release continuous doses of Buprenorphine over the course of about six months. Buprenorphine is a drug approved by the FDA to treat chronic pain and opioid addiction. Market Exclusive describes it as “the most widely prescribed opioid substitute for morphine, heroin, and other opiate addictions selling $2 billion a year in the United States.”
Dr. Michael Frost told CBS News that “[the implant] can help improve adherence to medication schedules… help stabilize the brain chemistry and take away the cravings.” Another benefit highlighted by Braeburn Pharmaceuticals CEO Behshad Sheldon to NPR is that Probuphine can only be accessed through surgery whereas Buprenorphine pills can potentially be diverted and abused.
WBUR ‘s ‘Common Health’ News also reported that clinical trials showed 88 percent of patients using Probuphine abstained from opioids, while this number dropped to 72 percent for those who were taking Buprenorphine pills.
Despite the positive ratings, this is not the first time Probuphine is up for evaluation and approval. ABC News reports that in 2012, the drug was rejected because it was releasing low doses of Buprenorphine that could not be used for treatment. This time, however, the company hopes the FDA gives its seal of approval.
Treatment Industry Reservations about Probuphine Implant
Initially, the FDA was set to make a decision on Probuphine on February 27, but this date was moved to the end of May. This is because of the changes recently made to the Risk Evaluation and Mitigation Strategy (REMS) law, according to Market Exclusive.
These delays and uncertainty over whether the drug will be approved continue to negatively affect the pharmaceutical company’s stock and the shareholders are keeping a close eye on the developments.
Of great concern to them are some of the issues raised about Probuphine. These include:
- High cost of treatment
Dr. Barbara Herbert, president of the Massachusetts Society of Addiction Medicine, lamented to NPR that even though this treatment is a “good idea”, the rumored costs of about $1,000 were too high. She said that it was “unconscionable” for pharmaceutical companies to make profits during this opioid epidemic.
- Alleged poor research
Tracy Rupp, Director of public health policy initiatives at the National Center for Health Research, said the expert panel should have never approved the implant because they did not determine whether it was safe or effective, according to USA Today.
- Doctor training and Implant replacement issues
All doctors involved in opioid treatment will need training on how to place the implants under the skin. Sheldon also wondered to Common Health News whether the implant replacements will be put in the same area of the skin or whether the doctor will need to cut open a different region, thereby leaving scars.
- Patient limits
Since doctors licensed to prescribe Buprenorphine have patient limits, it is not yet known whether there will be any patient limits for Probuphine use.
Fox61 News reports that once the drug is approved, Dr. Frost believes it can be available to the public by mid-summer. We can only hope that it will be effective in treating opioid addiction.