In the prior CRL, the FDA noted no concerns related with the clinical trial results, including the safety of STS101, and did not request additional clinical trials.
STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary nasal delivery device.
SNBL's corporate mission has been to support drug development and the improvement of medical technology to free mankind from suffering.
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SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule.

Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura By Investing.com