FDA Review Throws Cold Water on Probuphine Bup Implants  E-mail
Addiction Treatment Industry Newswire

03/20/2013 -ATIN- Long-acting buprenorphine implants, already brand named Probuphine by Titan Pharmaceuticals as the tiny specialty pharma moves through trials and FDA approvals for the implantable opioid replacement  therapy, got a decidedly negative review by FDA staffers in what is the key aspect of the implants -  their ability to completely replace daily dosing and thus solve a range of thorny bup issues ranging from diversion to proper dosing and even the possibility of cutting back on the highway robbery $150 to $300 monthly doctor's visits.

Supplemental Oral

In documents posted in advance of Thursday's meeting of the FDA  Psychopharmacologic Drugs Advisory Committee, reviewers said  that clinical trials showed 40% to 62% of those treated with the implant required supplemental oral buprenorphine. There were also significant safety issues with 2 percent of implant study participants developed postules and other site irritations versus zero from placebo, suggesting significant site irritation from buprenorphine.


The staff review suggests that Titan is a very long way off from market for its Probuphine, a product that when it might ever come to be available would likely be prohibitively expensive, while by that time, hopefully, a deep and widely available market in Subxone generics will have developed. Toward that end, Amneal Pharma, an aggressive Indian generics pharma startup that has just announced its intention to invest hundreds oAmneal Pharmaceuticals buprenorphine HCl and naloxone HCl tablets in 2 mg/0.5 mg and 8 mg/2 mg strengths, 30-count (Photo: Business Wire)
f millions in a new plant smack in the middle of the New Jersey pharma manufacturing corridor, where it will likely be producing the generic Suboxone the FDA very recently gave it the green light to start manufacturing. Amneal is one of the very first generics to have its version of Suboxone approved by the FDA, and in early March had 2mg and 8mg tabs on the market.

Blockbuster Peaks in 2012

It is very likely that Reckitt Benckiser - more famous in Europe for producing household products like Lysol and thus similar to our Johnson & Johnson, except that J&J has a HUGE multi company pharmaceutical presence while Suboxone is the only drug Reckitt produces - saw sales of Subxone peak in the U.S last year, where a a whopping $1.5B  was's the only time any addictions compound has ever even remotely got close to reaching the $1B blockbuster status.



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Comments (2)Add Comment
written by Kathy, April 30, 2013
I'm glad they are holding off on this. Suboxone is nothing but a synthetic opiate with all of the same effects and issues. The thought of having an opiate implanted into an addict scares the heck out of me. The idea is to get OFF of the opiates, not just switch to a different kind.

I would love to see more about Vivitrol. My daughter successfully used that to break a 7 year addiction. After 9 times through rehab, suboxone and methadone; all of which were unsuccessful, she has been clean since her very first shot of Vivitrol.
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FDA throws cold water on Probuphine BUP implants
written by milagros velez, March 21, 2013

I am glad FDA has not approved this method of treating addiction. Harm Reduction and support and therapy can work. I support the use of BUP and Methadone as an alternative to returning to a productive lifestyle but I stop at implants and does not say where it would be implanted? In the Brain?
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