Novel Therapies in the Pipeline for Migraine

Peter L. Salgo, MD: Let’s fit this class into some guidelines. I know the guidelines have not been updated for a few years. We have these new drugs. How would you integrate this class into the treatment guidelines, or are you on the committee?

Malaika Stoll, MD, MPA: Well, I think we’re all agreeing that we like the way they’re integrated now. The guidelines that came out were reasonable. For preventive care, they’re saying, “Try a couple of the other ones first. But, very quickly, if those aren’t working, we want you to progress to one that works.”

Peter Goadsby, MD, PhD: I think you should document a reasonable dose and a reasonable exposure. It’s not like you just take propranolol, 10 mg, for a week and then you’re ticking some sort of box. Physicians and patients should be honest so that the exposure gets done properly. When we turn around and say, “These people need these other treatments,” there’s some kind of reasonable relationship.

Malaika Stoll, MD, MPA: And, do they work for the person, right? Maybe they’re not going to work for everyone. That’s the other piece, too. “Once you start this, let’s make sure it’s working.”

Peter L. Salgo, MD: Oh, now there’s a concept. Is it effective?

Malaika Stoll, MD, MPA: Right. “Let’s make sure it’s working and not have you go back for these injections if they’re not.”

Peter L. Salgo, MD: Does that sound rational to you?

Jill Dehlin, RN: Yes.

Peter L. Salgo, MD: All right. We have other drugs in the pipeline, right?

Peter Goadsby, MD, PhD: We do.

Peter L. Salgo, MD: We have galcanezumab. Can you walk me through this?

Peter Goadsby, MD, PhD: Galcanezumab is a CGRP [calcitonin gene-related peptide] monoclonal antibody. There are randomized controlled trials in episodic and chronic migraine. It’s effective. There’s a randomized controlled trial that was just released at the American Headache Society a couple of months ago. In episodic cluster headache, it was shown that it worked. It failed in chronic cluster headache, which is interesting. So, we’re going to have a whole interesting discussion about where these drugs might find a role in episodic cluster headache. That’s a different discussion.

Peter L. Salgo, MD: We’ve got another one, fremanezumab.

Peter Goadsby, MD, PhD: Fremanezumab, again, is a monoclonal antibody to CGRP. It’s being developed in episodic and chronic migraine. Again, there are randomized controlled trials. Galcanezumab is injected subcutaneously, monthly. Fremanezumab has 2 ranges in dose in clinical trials. One option is monthly doses, and the second dose is basically done quarterly. Fremanezumab is being looked at in a randomized controlled trial in episodic cluster headache, but it hasn’t read out. Yet, it’s a chronic cluster headache study, just like the galcanezumab one that is being pulled for futility.

Peter L. Salgo, MD: And then there’s one that’s even further out, which is eptinezumab.

Peter Goadsby, MD, PhD: Eptinezumab, again, is a CGRP ligand monoclonal antibody. Particularly, it’s being studied largely by intravenous administration, either quarterly… Actually, the first study was 6 months and it’s effective in episodic and chronic migraine as well.

Malaika Stoll, MD, MPA: That’s great.

Jill Dehlin, RN: My neurologist is most excited about the last one. He said the efficacy is a bit better than with the subcutaneous drugs.

Peter L. Salgo, MD: How do we know this if it’s only in early trials? It’s always great in early trials.

Peter Goadsby, MD, PhD: We’ve seen phase III data for all of these medicines. I don’t see much daylight between them, actually.

Jill Dehlin, RN: Thank you.