NEW YORK (TheStreet) -- Last July, AcelRx Pharmaceuticals(ACRX) - Get Report was hit with an FDA rejection of its painkiller dispensing device Zalviso. Not surprisingly, AcelRx shares sank on the bad news, but Zalviso is expected to be resubmitted for a second shot at FDA later this quarter, setting up an opportunity for the stock to recover.
Zalviso is a handheld device which dispenses a small, dissolvable tablet of the painkiller sufentanil under the tongue of hospitalized patients recovering from surgery. If approved, AcelRx believes Zalviso's relative safety and ease of use for patients and hospital staff will make it an attractive replacement for traditional intravenous delivery of morphine.
The clinical trials of Zalviso conducted by AcelRx achieved their primary endpoints of efficacy and safety against the currently used intravenous morphine. The FDA's concerns -- and the reason Zalviso was rejected -- had to due with "optical system errors" with the device which dispenses the sufentanil tablet. Simply explained, the FDA found an unacceptably high error rate with a safety feature designed to warn nurses about the potential for device tampering. The FDA asked AcelRx to provide additional information and a fix to this software bug in the Zalviso device. The FDA also wanted AcelRx to improve the instructions on how to use the device. Since June, the company has been working to make the changes and provide the FDA with the information requested, which should be resubmitted to the agency this quarter.
It should also be noted that there has been turnover in AcelRx management in 2014. David Chung, the company's chief commercial officer, departed in June to assume the CEO position at a different medical device company. CEO Richard King assumed the duties of the role, however he too announced his pending departure in November. He is still with the company while it searches for his replacement and will be with it throughout the transition period.
The FDA's rejection of Zalviso last July was a setback but it also created an opportunity for investors to re-enter AcelRx at an attractive price.
This article is commentary by an independent contributor, separate from TheStreet's regular news coverage. At the time of publication the author held no positions in any of the stocks mentioned.