Many people might not be aware, but Suboxone tablets are being discontinued in March. That timing is perfect as the FDA is set to review Probuphine. Titan's subcutaneous Probuphine will be an ideal replacement for the tablets being pulled from the market, and I suspect the FDA will take that into consideration when making their decision. That also translates to lots of additional revenue for Titan on approval.
Reckitt Benckiser Pharmaceuticals is discontinuing Suboxone Tablets due to increased rates of accidental exposure in children compared to Suboxone Film. The company is working with FDA to ensure transition of patients from tablets to film is as smooth as possible. The company expects to discontinue the tablets in March 2013.
Tablets have only been replaced by a Film. You place it under toung same as pill, however taste better. All ready on market. Will have no inpact on sales of Suboxone. Our drug's best thing going for it is people do not have to take anything. So no need to worry about abuse, or selling drugs on street. Great for Jails and people who can not stick to a plan of staying clean
This really just boils down to if the Clinical Trial results are robust and efficient enough for FDA approval, and if the manufacturing end is in order
.I dont believe FDA is influenced by tablets being discontinued or the opiod abuse epidemic..
That comes into play only if NDA is approvable,then other elements become an important. secondary role..
The last trial already proved efficacy to be the same. The FDA does take into account "unmet medical need" when making their decisions. With the removal of tablets from the market in March that will leave a lot of patients with just the film option. That's a large void for patients which I believe the FDA will have to consider. That a huge positive for TTNP.
This was reported here a month ago by another story posted, leaving only the film and methadone for "first line" treatments as suggested by the guy on the street the other day. How many "feuer" treatments will there need to be thrown adam, until that guy, whom shall remain nameless, changes his tune?