Drugs in Development: Migraine

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Drugs in Development: Migraine Part 2

AXS-07, BHV3500, rimegepant, and eptinezumab are currently undergoing phase 3 clinical trials. On the other hand, a New Drug Application is yet to be filed for qtrypta and ALD1910 while lasmiditan is awaiting FDA approval.

AXS-07 BY AXSOME THERAPEUTICS

  • In March 2019, Axsome Therapeutics enrolled in a phase 3 MOMENTUM trial for AXS-07. The clinical trial is forecast to be completed by March 2020. 
  • Axsome Therapeutics announced its development of AXS-07 in November 2017.

LASMIDITAN BY ELI LILLY

  • The first phase 3 clinical trial for lasmiditan began in April 2015 and was completed by August 2016.
  • A second phase 3 clinical trial for the drug began in 2016 and was completed by June 2017. It was a randomized study with 3,005 participants.
  • In November 2018, Eli Lilly submitted a New Drug Application for Lasmiditan. The company is awaiting FDA approval for the drug.

EPTINEZUMAB AND ALD1910 BY ALDER BIOPHARMACEUTICALS

  • A randomized phase 3 clinical trial assessing the efficacy of Eptinezumab - otherwise known as ALD403 - began in November 2016 and rounded up by April 2018.
  • Alder BioPharmaceuticals announced in April 2019 that the FDA accepted its biologics license application for eptinezumab.
  • Alder BioPharmaceutical is awaiting FDA approval and plans to launch eptinezumab by early 2020.
  • ALD1910 is in the process of an investigational new drug (IND)-which will allow Alder Pharmaceuticals to carry out studies proving the efficacy of the drug in patients with migraine.

BHV-3500 AND RIMEGEPANT BY BIOHAVEN PHARMACEUTICALS

QTRYPTA BY ZOSANO PHARMA CORPORATION

  • Qtrypta has only been evaluated in a phase 1, open-label study. This was done in 2018.
  • Currently, Zosano Pharma Corporation is working on filing a New Drug Application for Qtrypta. The company anticipates doing this by the end of 2019 but has not made any statements about future clinical trials.

RESEARCH STRATEGY:

We commenced our search by reviewing the previous findings and heeding your comments. In order to specify the clinical trial stage for the provided drugs, we primarily relied on the ClinicalTrials.gov results database. We also expanded our search to the websites of the drug manufacturers for more details on the exact status of each drug. In addition, we reviewed their annual reports and earnings calls transcripts to be certain nothing was missed.
Sources
Sources