FDA Review Throws Cold Water on Probuphine Bup Implants

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 o

Amneal 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 sold…it’s the only time any addictions compound has ever even remotely got close to reaching the $1B blockbuster status.