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No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program

May 3, 2022

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Zosano Pharma’s headaches are intensifying. With the FDA again knocking back its transdermal migraine patch, the biotech has suspended its M207 program and made more layoffs to preserve its dwindling cash reserves.

The patch uses microneedles to deliver zolmitriptan, a selective serotonin receptor agonist that is already approved for use in the treatment of migraine attacks. Zosano reformulated the molecule, which is typically given orally, for transdermal delivery to accelerate absorption. However, the FDA has looked unfavorably on filings, issuing a complete response letter and then refusing to review a resubmission.

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