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Teva Pharmaceuticals has a new headache. As the Israel-based company pushes forward with its cost-cutting strategies, the company reported it is scrapping its chronic cluster headache program with fremanezumab following a pre-specified futility analysis of that study. This morning the Israel-based company announced the analysis revealed the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. There were no safety concerns with the CGRP inhibitor. With the disappointing news in hand, Teva said it will discontinue the chronic cluster headache trial. A long-term safety study in chronic cluster headaches with fremanezumab will also be discontinued, Teva said.

Interesting that the drug isn't working for chronic CH, but it is making a difference for migraine.

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Alder Biopharma (ALDR +14.8%) is up on almost 40% higher volume as investors believe that Teva's exit from developing CGRP inhibitor fremenezumab for chronic cluster headache is a positive for Alder's CGRP inhibitor eptinezumab, in Phase 3 development for chronic and episodic migraine.

So whilst the one above didn't work, this one might...

Very interesting Mike.

Thanks for the post.

Peter.

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The episodic cluster headache study is not affected and continues as planned.

So it is just the study for chronic CH that has been discontinued and not the episodic one, but no real information as to why one and not the other.

     Might be a tough study to pull off accurately due to the transitory nature of the beast. I know I've been fooled twice by the coincidental ending of an episode and the starting of a new "cure". One time I started taking St John's wart during a pretty rough episode and that very night I got zero headaches and no more after that either, I was totally convinced I had the bull by the horns. Six months later when they started up again I knew what to take. You already know how that turned out. It was a pretty rude awakening. >:(
  Sean

I'd have thought that it would be easier to do a study of chronic CH which by its very nature is ongoing and so using a headache diary and some statistical analysis you should be able to compare a baseline (i.e. before the trial) with whatever was given during the trial (drug / placebo).

The real complication would come from trying to do this for people who are episodic as you can't easily differentiate between an cycle that just didn't happen (all too easy with CH variability) and one that was prevented, unless the prevention isn't perfect in which case you'll spot the start / end of a cycle and would need to compare that cycle to previous cycles.