The consternation expressed by Skip Cummins yesterday during a conference call would appear to be well deserved.

Cummins, president and CEO of Cyberonics (Houston), developer of vagus nerve stimulation (VNS) therapy primarily for epilepsy and depression applications, has been pursuing regulatory approval of the application for treatment-resistant depression (TRD) for several months and years.

The company’s saga became incrementally more complicated over the past year-and-a-half, especially after an expert FDA neurological panel recommended approval of that application (Medical Device Daily, June 17, 2004), with the agency then issuing a “non-approvable letter” (MDD, Aug. 13, 2004), against its usual policy of following its panels’ recommendations.

Cummins termed that decision “shocking” and coming “out of the blue.”

That was followed by an agency reversal, however, with the FDA issuing an “approvable” letter last February, (MDD, Feb. 4, 2005) conditioned on the company receiving an okay for its final labeling, final protocols for a post-approval optimization study and other stated conditions.

Among the first signs of what seem to be mixed signals from the FDA came in early 2004 when Cyberonics said it was “blindsided” by changes in the agency’s position on trial protocols for the VNS depression treatment (MDD, Feb. 12, 2004).

The company also has received warning letters from the agency concerning its epilepsy treatment using VNS. This past April, Cyberonics reported that the agency had found its response to its concerns complete and adequate.

During yesterday’s conference call, Cummins said that the company had been aiming for a major rollout of the TRD treatment during the annual meeting of the American Psychiatric Association (APA; Arlington, Virginia), which gets under way tomorrow and runs through next Thursday in Atlanta.

Cummins said that the letter from the Senate Finance Committee would not change its plans to feature the system for TRD at the APA meeting.

Even without FDA approval before the meeting, Cummins said, the company’s “symposium, panel presentation, podiums, abstracts don’t change. Nothing changes.”