• DPMC Moderators: thegreenhand | tryptakid
  • Drug Policy & Media Coverage Welcome Guest
    View threads about
    Posting Rules Bluelight Rules
    Drug Busts Megathread Video Megathread

YES!!! Reckitt loses U.S. bid to block generic heroin addict drug

Jabberwocky

Jabberwocky

Frumious Bandersnatch
Joined
Nov 3, 1999
Messages
85,003
Reuters said:
LONDON | Mon Feb 25, 2013 8:31am EST

(Reuters) - U.S. regulators approved two generic versions of Reckitt Benckiser's heroin addiction drug and rejected its bid to block rival products on the grounds that stricter packaging rules were needed to protect children.

The British consumer health goods company's pharmaceuticals division makes most of its profit from Suboxone, a treatment containing buprenorphine that helps people addicted to opiates cope with ceasing to take them.

The company had been warning that generic competitors were likely to enter the market since its exclusivity status expired in 2009.

Hoping to shore up its position, Reckitt has been campaigning to persuade the U.S. Food and Drug Administration (FDA) to refuse applications from manufacturers unless they adopt stringent packaging standards.

But on Monday, Reckitt said it had been informed by the FDA that the regulator had approved two generic versions of Suboxone tablets in the United States.

Furthermore, the FDA said in its letter that it had received comments asserting that Reckitt's petition was an anti-competitive practice, and that it would refer the company to the Federal Trade Commission.

Last year, Reckitt voluntarily withdrew the sale of Suboxone tablets in the United States in favor of an individually sealed film version, which melts on the tongue, saying there was a higher risk of children mistakenly getting hold of tablets.

The FDA said there was not sufficient evidence to support the need for stricter packaging.

"While FDA welcomes and encourages sponsors to utilize unit-dose packing for their oral buprenorphine products, we do not believe the data at this time support refusing to approve applications that lack such packaging," it said.

A recent downward trend in accidental exposure of children to the drug could be attributed to many factors, including clearer labeling and a better understanding among patients and pharmacists of the dangers of an overdose, it said.

TIMING

"The timing of Reckitt's September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for this product was expected to begin, cannot be ignored," said the regulator.

The company said it was "disappointed" with the FDA's decision but would continue to work with the drugs regulator on safety enhancements.

"Reckitt Benckiser Pharmaceuticals remains confident in the value and benefits of Suboxone Film as the product is a significant advancement in product technology," it said in a statement on Monday.

The news wiped nearly 4 percent off the FTSE 100 company's shares, a reaction that Andrew Wood at Bernstein said was "overdone".

"In fact, we see this as a positive move in finally lifting off the cloud of uncertainty that has bedeviled RB's stock in recent years," he said.

Meanwhile, Deutsche Bank estimated that - assuming generics launch within a month and 90 percent of tab users switch within nine months - Reckitt's group profits would see a 2 percent hit in 2013.

"Had RB not repeatedly warned on the potential threat of a generic Suboxone tab entry, the valuation impact would have been far greater than it will probably end up being," the broker said, adding that it expected the firm's core household and over-the-counter business to do well in 2013.

The company, which makes products ranging from Strepsils lozenges to Cillit Bang cleaner, beat market forecasts on its 2012 performance earlier this month, leading the shares to a record high.

(Reporting by Rosalba O'Brien; Editing by Anthony Barker)
Click to expand...
http://www.reuters.com/article/2013/02/25/us-reckittbenckiser-idUSBRE91O0AW20130225

Also see: Make Way for Generic Suboxone
 
Last edited by a moderator:
Yeah, there really should be a generic for it.

toothpastedog said:
Cause now I don't have to choose between either IM/IV bupe or sublingual bupe (as intranasal bupe with the strips never worked for me :(), meaning I can get a significantly higher BA without sacrificing safety/limbs/veins. The idea of not running out early ever again thanks to not having to use as much (as I keep it to sublingual use with the strips) is also tantalizing...This is going to make it waaaay easier for me to complete my taper too :D

Shit, what a sad life I live :\ ...
Click to expand...

If you can make a solution for IM/IV, you can snort this liquid for IN use. :)
 
Captain.Heroin said:
Yeah, there really should be a generic for it.

If you can make a solution for IM/IV, you can snort this liquid for IN use. :)
Click to expand...

Oh and I don't disagree. My problem is with my shnoz. For whatever reason (maybe all those other drugs I used to snort as this is my route of choice) whenever I've tried to make suboxone strips into a solution to waterline I've found they buuuuuurn to the degree it's more painful than precipitated w/d. The best results I had were with using saline solution instead of water Ie.g. water+table salt), but it was still uncomfortable enough to make my ROA preference sublingual despite the poor BA.

I guess I could have tried a topical numbing agent, but I'm not that much of a dirty junkbox these days...

Hopefully all that doesn't mean I'm so forgone that I won't even be able to snort the generic pills they (I hope) come out with in the near future. I don't think this'll be a problem, as I had no problems with some dillies a couple weeks ago :\ ;)
 
toothpastedog said:
Oh and I don't disagree. My problem is with my shnoz. For whatever reason (maybe all those other drugs I used to snort as this is my route of choice) whenever I've tried to make suboxone strips into a solution to waterline I've found they buuuuuurn to the degree it's more painful than precipitated w/d. The best results I had were with using saline solution instead of water Ie.g. water+table salt), but it was still uncomfortable enough to make my ROA preference sublingual despite the poor BA.

I guess I could have tried a topical numbing agent, but I'm not that much of a dirty junkbox these days...

Hopefully all that doesn't mean I'm so forgone that I won't even be able to snort the generic pills they (I hope) come out with in the near future. I don't think this'll be a problem, as I had no problems with some dillies a couple weeks ago :\ ;)
Click to expand...
Oh damn! Thanks for sharing. I had never considered that as a possibility, I've never tried waterlining my solution before, I should try it with a little bit to see if it burns my nose.

I know after I quit snorting dope my nose was really sensitive due to all the damage, like during winter my nose will get really cold, etc. but I'll have to see.

Thanks for sharing though.
 
My pleasure! I know what you mean about your nose being tender and giving you problems when it's cold. After a couple years of putting ecp up my sinuses on a near daily basis it got to the point where, when it got cold, which it often did given I was in New England, my nose and surrounding facial tissue would get really dry and flake off (just like after sunny burn). No fun at all, although vit e cream did the trick most of the time. Below freezing winds probably made it worse...

(and for the record, never had any problem snorting suboxone pills in the past, or any other pill commonly snorted, although I cannot for the life of me deal with snorting methamp, that's even worse than the sub strip solution)
 
toothpastedog said:
My pleasure! I know what you mean about your nose being tender and giving you problems when it's cold. After a couple years of putting ecp up my sinuses on a near daily basis it got to the point where, when it got cold, which it often did given I was in New England, my nose and surrounding facial tissue would get really dry and flake off (just like after sunny burn). No fun at all, although vit e cream did the trick most of the time. Below freezing winds probably made it worse...

(and for the record, never had any problem snorting suboxone pills in the past, or any other pill commonly snorted, although I cannot for the life of me deal with snorting methamp, that's even worse than the sub strip solution)
Click to expand...

^ so true. I honestly cringe thinking about smoked/snorted methamphetamine. It burns nasally and tastes so awful smoked that I honestly don't see how people use it any other way other than oral, plugged, or IV.

I have heard that 2c-I burns much worse than cocaine/methamphetamine though, but I have never tried snorting 2c-I myself.

Even living in southern California, when it's the winter months like it is now, I often will walk around with something over my nose to keep it from getting painfully cold. Even if the rest of my body is warm, my nose will have a tendency to get cold without being covered. I should probably get a ski mask.
 
Fucking RB, they'll do anything to make money... First it was their attempted (now failed, thank gold) at preventing a generic pill from coming out. Now it's their introduction of 12mg and 4mg strip dosages. See:




Arg! I am looking forward to seeing how things work with the generic coming out (hopefully sooner than later)
 
I think it's a good thing that they have different dosages, but it's definitely a ploy on their behalf to elongate their monopoly over buprenorphine as a prescription medication.
 
Hilarious that RB also makes "chore boys", to the delight of crack smokers everywhere. I wonder if that is their number two in sales after suboxone? ;) It is so prevalent in cracked out areas, every corner store, even if it's just a beer/cig/snacks place, has a chore boy section. Hilarious.
 
Anyone know if these generic Suboxone are able to be snorted just like the old ones? And has anyone taken them and know if they work any better or less? May sound like a stupid question but I just wondered cos anytime I've ever heard of pills changing up their stuff they always put something in it that blocks the user from being able to snort or shoot them easily. Like when IR's would gel up in your nose....
 
First off they won't be out yet for a little while, or so I gather. I'd bet they'd be very similar to the original suboxone or other sublingual pills - so it's almost guaranteed you won't be running into the problems people did when the switched the OC --> OP formula. Sublingual generally work well for insulfation (well, not medically speaking, and it still depends what inactive ingredients and such is in them), so I wouldn't worry.
 
So happy this crap doesn't exist here. Here it's the usual subutex/subuxone with lots of generics available for subutex at least.
 
The Suboxone? Subutex is generic here too, sub docs are just very wary to prescribe it for fear of being seen as something "easier or more prone to abuse" than suboxone (as if the naloxone in suboxone supposedly prevents any abuse of bupe :\).
 
Hmm, I tried the generic Subutex and it was WAY less potent. Didn't dissolve well either... I hate generics...
 
weird i didnt know they made 4mg and 12mg strips....then again i was off suboxone before the strips came out. great news tho about the generic coming out, without insurance my rx for subs was like 400 some dollars for 56 8mg pills. Insane!
 
You must log in or register to reply here.
Top