Spirig Gains First Approval For S-Optifen

Spirig, based in Egerkingen, Switzerland, has received its firstapproval from the Swiss regulatory authorities for S-Optifen (dexibuprofen), the active S(+) enantiomer of ibuprofen.

There are distinct advantages of dexibuprofen, classed as a New Chemical Entity, over racemic ibuprofen, including the potential for dose-reduction. Studies have demonstrated that dexibuprofen at 150mg and 300mg strengths is equivalent to 200mg and 400mg racemic ibuprofen tablets for analgesic, antiphlogistic and antipyretic effects.

Safer Than Ibuprofen In addition, dexibuprofen has a better safety and pharmacokinetic profile compared to ibuprofen. The reason for this is that racemic ibuprofen contains both the S(+) and the R(-) enantiomers. However, S(+) is more effective and is responsible for the therapeutic effect. The R(-) is pharmacodynamically inactive and is converted in vivo to S(+), but this conversion is often incomplete, leading to the accumulation of R(-)-ibuprofen in fatty tissue. One complication in the development of the product was that, due to the nature of S(+)-ibuprofen, it is difficult to compress into tablets. This was solved using Spirig's subsidiary Pelletech's pelleting technology.