FDA Asks For Additional Data on Implant to Treat Opioid Addiction

The Food and Drug Administration (FDA) this week asked for more information on an implant designed to treat opioid addiction, before making a decision on whether to approve the drug, according to Bloomberg News.

Probuphine is a long-acting version of the opioid dependence medication buprenorphine. It is implanted under the skin of the upper arm, in a procedure that takes about 10 to 15 minutes in a doctor’s office. It remains in place for about six months. The FDA asked for more information on the effect of higher doses of Probuphine, and on how doctors would be trained to insert and remove the implant.

In March, an advisory panel to the FDA recommended the agency approve Probuphine, made by Titan Pharmaceuticals, but voiced concerns about the safety of the manufacturer’s marketing plan.

Members of the panel said they were concerned about the safety of the company’s marketing plan, because of the potential for abuse of the drug. They also said they were not convinced the intended dose of Probuphine would be effective enough.

Doctors must be trained to implant the drug, and some of the FDA advisors said they were concerned Titan had not adequately planned for the training.

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    Joy

    June 1, 2016 at 12:20 AM

    I’m scared to death of this inplant. Isn’t the purpose of these drugs to get off eventually and to ween the patient of the subox or subutex because I didn’t think these drugs are meant for long time use. Isn’t this method going right into the blood stream very hard on kidneys, heart & other organs.Need answers, how dangerous is this, from a very concerned mother.

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    Jonathan Eddy

    May 17, 2016 at 3:13 PM

    This sounds like a great idea, I see people that stop taking their meds to use all the time. Are they using this yet? Has it been approved?

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    Cap

    November 7, 2015 at 12:12 PM

    I agree with Carol. A long-term Buprenorphine implant would be a huge help for opiod-addicted patients. One problem I’ve seen with the typical treatment (i.e. sublingual) is the lack of patient adherence. Many patients will take the medication at the correct interval, then stop for a day or so before a planned “relapse”.

    I believe an extended-release form of Buprenorphine, like Probuphine, could alleviate the temptation for a patient to go on a “Suboxone Vacation”. I’m going to follow the progress of Probuphine and hope that it comes to market sooner than later – my brother would benefit so much from this (every once-in-a-while, he stops taking suboxone so he can use his drug of choice).

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    Carol Gunderson

    August 26, 2013 at 12:15 PM

    I like the idea of an implant. It would help keep us on a schedule. When will it be available and a list of Doctors who can do this. carol

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