Why no 5ASA Foams?

The foam based rectal meds are so much easier to use/less messy. Curious why no foam based Rowasa?

I just found this after googling mesalamine foam...I'm not sure this stuff is available here in the US yet, but if anyone is currently using it please chime in.


Clinical

Mesalamine foam can replace liquid mesalamine enemas for ulcerative colitis
Last Updated: 2009-01-06 17:50:47 -0400 (Reuters Health)

NEW YORK (Reuters Health) - In patients with proctitis and proctosigmoiditis, a mesalamine foam can be substituted for difficult-to-retain mesalamine liquid in therapeutic enemas.

In the December issue of the American Journal of Gastroenterology, an international team led by Dr. Antoine Cortot at Hopital Claude Huriez in Lille, France, points out that because mesalamine induces remission in ulcerative colitis, a placebo-controlled trial would have been unethical.

The researchers therefore conducted a noninferiority study, in which 375 patients were randomized to treatment with either mesalamine foam, 1 g/80 mL/d, or mesalamine liquid enema, 1 g/100 mL/d for 4 weeks. All patients had mild-to-moderate ulcerative colitis and disease extending at least 5 cm from the anorectal junction but not beyond the splenic flexure.

"Remission rates...in foam versus liquid were 68.3% versus 73.6% in per protocol population...and 66.7% versus 70.5% in intention-to-treat population," the researchers report. Both treatments were well tolerated, they add.

"Although the noninferiority of mesalamine foam could not be strictly demonstrated at week 4 in the per protocol analysis, it was achieved in the intention-to-treat population," the investigators write.

They add that because the trial had enrolled mostly proctitis and proctosigmoiditis patients, their results mainly concern these two forms of ulcerative colitis and it was not possible to reach conclusion for left-sided ulcerative colitis.

Nevertheless, they conclude, "Mesalamine foam enema represents a clinically efficient and well-tolerated therapeutic alternative to mesalamine liquid enemas in patients with mild-to-moderate active proctitis and proctosigmoiditis. It may be especially appropriate in case of poor tolerance of enemas because of acute rectal inflammation."

Am J Gastroenterol 2008;103:3106-3114.

Sometimes this country just sux : (

Thanks, Old Hat...I just got onto the Shire Pharma website, selected the United States group, and sent an email.  Maybe if enough of us do the same, they will take note and realize that there is a market for this. 

Jo

Asacol makes a foam in Britain....maybe you could email them and enquire if it'll be made in N. America?

q

I think that the mesalamine foam is manufactured by Falk in Germany-- then it is distributed thru other pharmas in the UK, Europe, & Australia. Last yr when I did some searching on the Web, I found out that the distributor in Australia is an affiliate of Shire. Julee70 actually bought a supply of the foam while traveling abroad last fall-- so she may be able to confirm the manufacturer from the labels she has on her packages. I think Knitty_Cat had mentioned that it's called "Colifoam" in Australia. To bbc, you won't hear about foam from the Rowasa manufacturer-- it's a different pipeline. In fact, Rowasa was sold by one pharma to another in the U.S. a couple yrs ago. We did a thread on it after some members reported having their supply temporarily cut off at regional pharma warehouses! / Old Hat (nearly 30 yrs with left-sided UC ... [etc.])

I bought the Asacol foam while on in Europe. It was so cheap at the pharmacy -- about $300 for enough to use it nearly every day for a year -- that I bought a year's supply. Of course I couldn't use my medical insurance (they'd have no idea what it was anyway) but I was happy to just have a chance to buy it.

So far, I've found it to be very helpful for maintaining remission, though I've been fighting a flare recently and switched to the cortifoam for the short-term.