The battering that AcelRx ($ACRX) has been subjected to on Wall Street won't stop. The biotech announced that the FDA won't even sit down to discuss regulators' demand for a new clinical trial to assess the efficacy of its pain drug/device Zalviso. And increasingly skeptical investors weighed in on the biotech's most recent setback by pummeling shares once again.
The company's stock is down 27% this morning.
This is the latest assault on a company that first tried to reassure investors that the FDA's initial rejection last summer could be handled without a new, lengthy and expensive trial. But in March AcelRx execs had to beat a hasty retreat, noting that the agency did require a new study. And today's release makes clear that the agency isn't about to relent on its demand.
According to AcelRx, the FDA refused its request for a Type B meeting on Zalviso, restating its demand for a new study. The biotech added that it now plans to huddle with attorneys on what its next step will be. "We will be considering all options to determine a pathway forward for Zalviso including the possibility of dispute resolution through one of the FDA prescribed pathways as well as conducting additional clinical or Human Factors studies," the company noted.
"As part of the Type B meeting, we intended to share with the division the results of the bench testing and the Human Factors studies they had requested as part of the CRL and Type A meeting, and further discuss their desire for additional clinical work. We continue to believe that an additional clinical study should not be required to demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase III clinical studies, as well as the bench testing and Human Factors studies," noted Howie Rosen, interim chief executive officer of AcelRx Pharmaceuticals, in a statement.
Zalviso is being billed as an easier and safer method for allowing hospital patients to self-dose using a sublingual microtablet of the opioid sufentanil, replacing IV systems now in use. The system would be marketed as an improvement over IV methods now used in hospitals
Germany's Grunenthal paid $30 million upfront and promised up to $220 million more last fall as it licensed European and Australian rights to the pain therapy.
- here's the release