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A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers

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Trial Profile

A Randomized Open-Label Three-Way Crossover Study to Compare the Pharmacokinetics, Safety, and Tolerability of Two Lots of M207 3.8 mg (Administered as Two 1.9 mg Patches on the Upper Arm for 30 Minutes) and Intranasal Zolmitriptan 5.0 mg x 2 Doses in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2022

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At a glance

  • Drugs Zolmitriptan (Primary) ; Zolmitriptan (Primary)
  • Indications Cluster headache; Migraine
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Zosano Pharma

    • Most Recent Events

    • 17 Mar 2022 According to a Zosano Pharma media release, company is communicating with FDA to evaluate next steps following their letter indicating the resubmitted M 207 New Drug Application (NDA) did not constitute a complete response to deficiencies identified by the FDA's Complete Response Letter (CRL). The company is also in discussions with the FDA to determine if there is a viable option to pursue approval of M 207 using the currently available clinical data.
    • 04 Oct 2021 According to a Zosano Pharma media release, the company plan to provide update on resubmission plans after receiving written feedback from the FDA, which is expected to occur by mid-December.
    • 04 Oct 2021 Results published in the Zosano Pharma Media Release.
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