What happened
Shares of AcelRx Pharmaceuticals (ACRX 3.00%) jumped 16.5% on Monday as investors buy shares ahead of a Food and Drug Administration advisory committee meeting to review its marketing application for Dsuvia, which is scheduled for Oct. 12.
So what
AcelRx is trying to get Dsuvia approved for the management of moderate-to-severe acute pain in medically supervised settings. The active ingredient, sufentanil, is approved for intravenous (IV) and epidural administration, but AcelRx developed a sublingual tablet that dissolves under the patient's tongue in hopes that it will avoid dosing errors associated with IV administration.
The company received a complete response letter -- the FDA's euphemism for a rejection letter -- last year in which the agency asked for more data from patients treated at the maximum dose, and also requested some changes in the instructions that accompany the drug on how to use it. Presumably, the FDA will ask the committee of outside experts about AcelRx's response to both topics when it meets next month.
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While the meeting is scheduled for Oct. 12, investors should circle Oct. 10 on the calendar as well since two business days before the meeting, the FDA usually publicly posts the briefing documents it sent to the committee members. While the committee will make a recommendation about the approvability of Dsuvia, the FDA has the final say, so the reviewers' comments in the briefing documents are often more important than the meeting itself.
Now what
Traders who think in the short term often buy ahead of binary events like clinical trial results, FDA committee meetings, and FDA decisions, so investors should expect that AcelRx could continue to be volatile until the briefing documents are posted and the committee makes a recommendation at the meeting.
The FDA is scheduled to make a decision on or before Nov. 3, although that's just a goal set by the Prescription Drug User Fee Act (PDUFA) and not a hard deadline the agency absolutely has to meet. With less than a month between the meeting and the PDUFA date, investors should be prepared for a potential delayed decision.
