Author Interviews, Pain Research, Pharmaceutical Companies / 04.06.2018
Zosano Developing Dermal Patch to Quickly Relieve Migraine Pain
MedicalResearch.com Interview with:
Dr. Peter Schmidt, MD, MSc
Senior Director, medical Affairs and Clinical Development
Zosano Pharma
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This was a post-hoc analysis of Zosano’s pivotal efficacy trial using its adhesive dermally-applied microarray (ADAM) zolmitriptan formulation, M207. The trial found that M207 was effective versus placebo for the co-primary endpoints of pain freedom and most bothersome symptom (MBS) freedom, both at two hours. The MBS endpoint was just ratified as a new endpoint in the FDA’s February 2018 guidance for acute migraine trials. The stated aim of this new endpoint is “…to better align the study outcome with the symptom(s) of primary importance to patients…” This is logical, as a given migraine patient may not experience all four previous symptom endpoints (pain, photophobia, phonophobia, nausea).
Dr. Peter Schmidt, MD, MSc
Senior Director, medical Affairs and Clinical Development
Zosano Pharma
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This was a post-hoc analysis of Zosano’s pivotal efficacy trial using its adhesive dermally-applied microarray (ADAM) zolmitriptan formulation, M207. The trial found that M207 was effective versus placebo for the co-primary endpoints of pain freedom and most bothersome symptom (MBS) freedom, both at two hours. The MBS endpoint was just ratified as a new endpoint in the FDA’s February 2018 guidance for acute migraine trials. The stated aim of this new endpoint is “…to better align the study outcome with the symptom(s) of primary importance to patients…” This is logical, as a given migraine patient may not experience all four previous symptom endpoints (pain, photophobia, phonophobia, nausea).

























