In yet another uninspiring piece of news for AcelRx (ACRX), the company reported on Monday that the FDA wants another clinical study of the company’s Zalviso patient-controlled analgesic device prior to re-considering its approval. AcelRx received a Complete Response Letter in July of 2014 (an FDA rejection) and has since run bench testing and two Human Factors studies on the Zalviso System. The company planned to re-submit its New Drug Application this quarter before the latest FDA communication, which came last week, put in a halt.
The CRL last summer contained requests for additional information on the Zalviso System to ensure proper use of the device. The requests included data demonstrating a reduction in the incidence of system errors; changes to the device’s Instructions for Use; and additional data to support the Zalviso nanotab’s shelf life. According to the company – and this is the sticking point – in the CRL there were no requests to conduct additional human clinical studies. The CRL identified Human Factors studies as appropriate to assess the Instructions for Use changes.
The FDA now wants an additional clinical study to assess the risk of inadvertent dispensing and overall risk of dispensing failures. According to the company, the FDA has yet to see any of the bench testing or human factors testing results.
AcelRx says they had previously obtained confirmation from the FDA that the protocol designs for the bench testing and the Human Factors studies were acceptable. On a conference call Monday evening, executives said that their last correspondence with FDA on the protocol occurred in February, and that this latest news comes as a major surprise.
For investors, the biggest question may be reliability. Was this a complete surprise, or has the company been less than forthright about its regulatory correspondence? The string of bad news coincides with a series of departures at the executive level, as well. In June of 2014 (before the CRL), CCO David Chung left the company, and CEO Richard King resigned in November.
Just as pertinent: What will the FDA want to see; How long will it take; and How much will it cost? AcelRx ended the year with $75 million in cash and burns around $10 million quarterly.
