Avenue Therapeutics Inc.'s injectable pain drug tramadol significantly reduced pain in patients following surgery compared to placebo, meeting the main goal in a late-stage study.
Tramadol is a synthetic, dual-acting opioid with less potential for abuse and a lower risk of dependence than conventional narcotics.
The company's second pivotal phase 3 study evaluated intravenous tramadol for pain management in 370 patients who have undergone abdominoplasty surgery, or the removal of excess flesh from the abdomen. The patients received either 50 milligrams of tramadol, placebo or 4 milligrams of intravenous morphine.
Patients who received tramadol showed improvement in pain reduction over 24 hours after the surgery compared to placebo, while tramadol and morphine showed similar results. The study also met its secondary goals of reducing pain 24 hours after surgery, and total consumption of rescue medication, which is a drug that can be administered to immediately relieve symptoms in the event a patient does not respond to an investigational therapy.
New York-based Avenue Therapeutics previously evaluated tramadol in 409 patients who underwent bunionectomy surgery to remove a bunion or enlargement of the joint at the base of the big toe, with the phase 3 study meeting its main goal.
Tramadol is already approved in an oral form in the U.S. for moderate to moderately severe pain in adults. The company plans to submit a new drug application for the IV formulation to the U.S. Food and Drug Administration at the end of the year.