Avenue Therapeutics Doses First Patient in Phase 3 Safety Trial

Avenue Therapeutics (NASDAQ:ATXI) announced the dosing of the first patient for its phase 3 safety trial of IV tramadol for the management of moderate to moderately severe pain.
As quoted in the press release:

“We are pleased to announce the dosing of the first patient in our Phase 3 safety trial of IV tramadol. This safety study is a key component of our pivotal Phase 3 development program and will be used to support our planned new drug application (NDA), which we hope to submit to the U.S. Food and Drug Administration in late 2019,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We believe that IV tramadol, which has been used widely outside the U.S., has the potential to fill the gap between IV acetaminophen/NSAIDs and conventional IV narcotics, and may help circumvent the use of conventional narcotics. We look forward to rapidly advancing our pivotal program, which will bring us closer to our goal of making available the first Schedule IV intravenous opioid in the U.S.”

The Phase 3, multicenter, open-label trial will evaluate the safety of IV tramadol 50 mg in the management of postoperative pain following surgery. The trial will enroll approximately 250 patients to receive 50 mg of IV tramadol over 15 minutes at zero, two and four hours, then once every four hours thereafter.

Click here to read the full press release.

Source: globenewswire.com