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BioWorld - Sunday, May 3, 2026
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Home » Human interest story: CRL wants Acelrx data on dose, text to prevent device flubs
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Human interest story: CRL wants Acelrx data on dose, text to prevent device flubs

Oct. 13, 2017
By Randy Osborne
Acelrx Pharmaceuticals Inc. CEO Vincent Angotti said he was “hesitant to put a timeline on this until we get further clarification from the FDA” regarding what’s required to satisfy the agency’s issues raised in a complete response letter (CRL) related to its NDA for 30-mg sublingual tablet Dsuvia (sufentanil), an opioid therapy that’s intended to reduce moderate to severe acute pain as well as dosing errors that can happen with intravenous administration.
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