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Re: What can be used to mimic tianeptine in US?

Posted by sam123 on September 18, 2007, at 9:15:43

In reply to Re: What can be used to mimic tianeptine in US?, posted by sam123 on September 18, 2007, at 9:10:06

BTW, my pdoc has people on Stablon here in the USA, the drug can be imported.

Here is the full story:

" Tianeptine was first synthesised in 1981(?) by French researchers Antoine Deslandes and Michael Spedding. It has been developed and marketed since the late 1980s as the antidepressant Stablon by secretive, privately-owned Servier, the innovative French drug giant. Tianeptine is sold in Europe, Latin America and Asia. It is not marketed in North America because its patent has expired. To gain a US product license, a raft of costly new clinical trials would be needed by the FDA. Unfortunately, American regulators are habitually sceptical of the calibre of European medical science. Even after FDA approval, tianeptine/Stablon could be sold only cheaply due to generic competitors. Commercially, this might not seem an insoluble problem: structurally, tianeptine may be considered a modified tricyclic, and patentable analogues of tianeptine do exist, notably hetero[2,1]benzothiazepine derivatives. But if and when any such analogues will be commercialised is uncertain. No evidence exists that they are therapeutically superior to tianeptine. Another option might exploit how tianeptine sold as Stablon (etc) is a racemate; the l-isomer is more therapeutically active than its molecular sister. The design of single-isomer "chiral" drugs allows corporate patent lawyers to extend the patent life of old medicines. Thus tired SSRI antidepressant citalopram/Celexa was relaunched in 2002 as expensive new s-citalopram/Lexapro; and patent-expired modafinil/Provigil will soon be relaunched as expensive new r-modafinil/Nuvigil. This route hasn't been pursued yet with Stablon. In fact tianeptine may finally reach the USA branded not as an antidepressant, but in the guise of a treatment of Irritable Bowel Syndrome (IBS). For in 2004 Vela Pharmaceuticals registered a patent for the use of tianeptine to treat IBS. In March 2006 Pharmos Corporation acquired Vela. Tianeptine for IBS is now in "late-preclinical development" (mid-2006). If and when a medicine gains a US product license, physicians can then prescribe it "off-label" for whatever they see fit, including depression. But this prospect is several years away at best."




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