Replies to post #162393 on Amarin Corp Plc (AMRN)

[Jt0082]

Combination with statins is a ‘compliance play’ and while it’s novel and AMRN has the IP, this is about the only time I agree with Phyr’s biased negative agenda: very difficult to do as which statin would you chose and which dose? Too many options. Possible I guess but difficult...

[Pyrrhonian]

Patients prescribed omega 3 that are are also on statin medication are told to take them with the statin. There is evidence of some additional benefit when taken together (see COMBOS trial).

This is interesting btw: numerous studies were done to determine if 4g Lovaza taken with statin would inhibit the absorption of the statin, and showed no inhibition:

Drug-Drug Interactions

Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily coadministration of simvastatin 80 mg with LOVAZA 4 grams did not affect the extent (AUC) or rate (Cmax) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin, at steady state.

Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily coadministration of atorvastatin 80 mg with LOVAZA 4 grams did not affect AUC or Cmax of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.

Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily coadministration of rosuvastatin 40 mg with LOVAZA 4 grams did not affect AUC or Cmax of exposure to rosuvastatin at steady state.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021654s041lbl.pdf

I still think FDA will require AMRN to conduct a similar study as the above but replacing Lovaza with mineral oil. That’s why I’m gonna straddle/strangle options through PDUFA.