FDA Panel In Favor of Opioid Implant to Treat Addicts : Sectors : Venture Capital Post

By Staff Writer

Jan 14, 2016 10:26 AM EST

ST. JOHNSBURY, VT - FEBRUARY 06: 'Buck' who is 23 and addicted to heroin, prepares to shoot up Suboxone, a maintenance drug for opioid dependence that is also highly addictive on February 6, 2014 in St. Johnsbury, Vermont. Vermont Governor Peter Shumlin recently devoted his entire State of the State speech to the scourge of heroin. Heroin and other opiates have begun to devastate many communities in the Northeast and Midwest leading to a surge in fatal overdoses in a number of states. As prescription painkillers, such as the synthetic opiate OxyContin, become increasingly expensive and regulated, more and more Americans are turning to heroin to fight pain or to get high. Heroin, which has experienced a surge in production in places such as Afghanistan and parts of Central America, has a relatively inexpensive street price and provides a more powerful affect on the user. (Photo : Spencer Platt/Getty Images)

The Food and Drug Administration advisory committee has approved the use of rod implants that will slowly administer drugs into patients with opioid addictions. The implant's manufacturer is New Jersey-based Braeburn Pharmaceuticals.

The probuphine implant consists of four, small metal rods. Each rod secretes buprenorphine, a drug that helps with the withdrawal symptoms and reduces cravings.

Traditionally the buprenorphine drug is taken as a pill or dissolvable film under the tongue. Patients then have the problem of remembering to take their pill or film under normal circumstances. So because the drug is implanted, the patient is unable to forget to take their daily dose.

Dr. Michael Frost, with CBSNews, found the implant to be promising, saying, "It can help improve adherence to medication... helps stabilize the brain chemistry and take away the cravings."

Another problem the implant solves is the possibility that the patient will relapse and try to sell their medication for more opioids. It's the reason why such drug treatments are strictly regulated, with clinics usually administering one dose per day.

Despite the good benefits the implant will provide patients, there is a problem with the clinical trial of the device that has worried some of the doctors on the committee. USA Today spoke to Tracy Rupp, director of public health policy initiative at the National Center for Health Research, who described the findings of the clinical study.

"It is disappointing that the advisory committee set such a low bar for safety and effectiveness. Is probuphine effective? We still don't know because the study was poorly designed and missing data."

Also, the implants can last only for six months, even though most treatments need to be dispensed for years. So the question becomes what to do with the implant after the end of its six months and currently the answer is not clear.

Ars Technica described another problem with the implant is that patients usually get their dosage adjusted during the beginning of their treatment. So if the dosage of the implant is already fixed, then the doctor will have to prescribe supplementary oral doses, which would remove the need of the implant.

The implant hasn't been approved yet - only further along in the process. The FDA committee voted 12 to 5 to recommend that the regulatory agency approve the implant for use. Once the regulatory agency approves the implant, then the treatment would be available nationwide.

Opioid additions are found throughout the US in people who are addicted opioids such as painkillers and heroin. The Centers for Disease Control and Prevention have reported that overdoses on opioids kill 44,000 Americans each year, doubling the rate between 1999 and 2013.

With such sad statistics, it is understandable why the FDA would want to find a solution to the epidemic as soon as possible. However, due to some concerns of the committee, it is possible that the desperate need for a solution is causing those in favor of the implant to ignore the possibilities of future complications. It is up to the FDA to make the final ruling.