Six months after experiencing problems with patient accrual for a pivotal clinical trial, Neurex Corp. said it has scheduled a meeting with the FDA to get its SNX-111 analgesia program back on track.
"This is one of the few opportunities to have a private discussion with both FDA reviewers and the advisory committee," Neurex chairman and CEO Paul Goddard said. "We are interested in getting their help and guidance to reach our endpoint as soon as possible."
SNX-111 is a synthetic pain relief peptide based on a derivative from the venom of the conus snail. The compound specifically blocks N-type calcium channels and inhibits neurotransmitter release. Neurex, of Menlo Park, Calif., in collaboration with Medtronic Inc., of Minneapolis, is testing the compound in two pivotal trials. One in malignant pain associated with cancer and AIDS and another in severe neuropathic pain such as that associated with failed back surgery.
Neurex originally planned to include 200 patients in each study, but in September, the company said it was having difficulty accruing patients into the malignant pain trial. However, it has added 36 participating medical centers in order to boost accrual and hopes to persuade the FDA to accept a malignant pain trial of 100 patients rather than 200. "Because our early results are so promising, we hope to show efficacy in the malignant pain trial with 100 patients," Goddard said.
The closed meeting is scheduled for late March.
The analgesia trials of SNX-111 should reach full accrual by year end and Goddard said he expected the company to file a new drug application three to six months after the trials have reached accrual.
Neurex stock (NASDAQ:NXCO) lost $0.25 Tuesday to close at $16. * Lisa Seachrist