- AcelRx Pharmaceuticals Inc. will have to wait longer for a chance at breaking into the U.S. pharmaceutical market, as the Food and Drug Administration has rejected the West Coast biotech's pain medication.
- According to AcelRx, the agency explained in a complete response letter (CRL) how it needed more safety data on the maximum dose of Dsuvia included in the drug's proposed label. The FDA also suggested changing the administration instructions to make them clearer and testing those revisions with a human factors study.
- Though the agency had other recommendations in the CRL, they were largely "boiler plate commentary" compared to the two main issues, AcelRx CEO Vincent Angotti said during a Thursday investor call.
AcelRx leadership didn't specify how long it would take to address the FDA's concerns — and, in particular, the dosing safety data from at least 50 patients — but execs did seem optimistic that a resolution was on the horizon.
"We'd be hesitant to put a timeline on this until we get further clarification from the FDA to address that particular commentary," Angotti said. "As it relates to the human factor study, they're typically very efficient in nature and can be done at a rapid pace. Our concentration with timeline would be the collection of data related to those 50 patients — and we can't tell you exactly whether that means an additional study or data on file that we might have."
Even with that vote of confidence, investors didn't take the news well. AcelRx stock opened at $2.10 per share on Thursday morning, down nearly 61% from the prior day's close.
For long-term AcelRx shareholders, this is sort of deja vu. The company received a CRL back in 2014 too for its other under-the-tongue pain medication Zalviso (sufentanil sublingual tablet system). While the drug has since gained approval in Europe, AcelRx still hasn't resubmitted it with U.S. regulators — though that move should come before the end of 2017.
With the new setback for its 30 microgram Dsuvia (sufentanil sublingual tablet), it now looks like Zalviso may make it to market first in the U.S. On the plus side, AcelRx believes it can transfer some of its commercialization prep for Dsuvia to its other main drug.
"There is a significant overlap as it relates to that customer base for these particular products in the actue pain management scenario," Angotti said. "So the planning we've done for Dsuvia certainly does bleed into Zalviso."
"We have planned a staged launch towards the start of next year with Dsuvia where we would start with potentially 10 to 15 sales representatives and over the course of the year work that up potentially towards 40. I think you could consider a similar application for Zelviso, and in the event that we did execute that infrastructure, it certainly would be efficient to roll Dsuvia into that."
Still, the Dsuvia rejection is a hard hit to AcelRx's potential revenues. The company has estimated peak annual sales of $1.1 billion for the drug. At the end of the third quarter, it had $67.9 million in cash, according to company leadership.