- AcelRx Pharmaceuticals (ACRX +26.4%) is up on a 10x surge in volume on expectations of a positive vote from an FDA advisory committee this Friday related to pain med DSUVIA (sufentanil sublingual tablet). Shares were down over 50% at one time premarket before recovering.
- The company appears to have sufficiently addressed the review team's concerns over the safety of the 30 mcg tablets at maximum dosing and the risk of misplaced tablets, two areas cited in the CRL the company received in response to its original filing.
- To address the dosing issue, ACRX lowered the maximum daily dose to 12 tablets from 24 and provided new pooled safety data. To address the potential for misplacing tablets, it modified the directions for use and conducted another human factors study (page 6 in the FDA briefing doc).
- Previously: FDA releases briefing docs ahead of Ad Com review for AcelRx's pain med Dsuvia (Oct. 10)
- Now read: FDA releases briefing docs ahead of Ad Com review for AcelRx's pain med Dsuvia
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