|AcelRx CEO Richard King|
When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required--suggesting it could be back in front of regulators quickly--and investors responded with a swift punch to the gut, cutting the value of shares by more than 30%. This morning the biotech amended that by saying a new study is needed after all, and investors responded with a punch in the face, sending shares down by more than 40%.
Even last July the Redwood City, CA-based biotech's position with the FDA was more than a little murky. According to AcelRx ($ACRX), the FDA wants to see more bench data related to errors using the system, changes in operating instructions and "additional data to support the shelf life of the product." Some of that additional info may have already been filed with the FDA, according to the Redwood City, CA-based company, but some added work would be needed as well.
It came as more than a bit of a nasty surprise that now, in addition to the work done over the past 8 months, "an additional clinical study is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures."
As a result of the setback, the biotech says it will not be filing a complete response to the FDA this quarter. Instead it plans to follow up with new talks with regulators to clarify what needs to be done, and no substitute timeline was offered.
AcelRx started today with a market cap of about $382 million. Its CEO, Richard King, announced he would step down last November in the aftermath of the first setback. As of today, though, he's still CEO.
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