The FDA just doesn’t want to meet with AcelRx Pharmaceuticals (ACRX).
Reported alongside the company’s first quarter financial update, AcelRx’s request for a Type B meeting with the FDA, submitted in April, has been denied by regulators. The FDA still wants the company to run a new clinical study of its Zalviso analgesic drug/device combo, despite the company’s assertions that the safety and efficacy of the Zalviso System has already been established in multiple completed Phase 3 clinical studies, bench testing, and completed Human Factors studies.
ACRX made new 52-week lows following the news on Monday.
It’s been a rough road since the FDA rejected an application for approval of the Zalviso system last July. AcelRx has been trying to avoid running another clinical study of the system, even while looking for a new chief executive.
The issue at hand – whether cash and equivalents of $64.4 million will get the company through another sizable clinical study and then across the finish line with a re-filed New Drug Application. ACRX burns about $9-10 million quarterly.
