Trevena Inc (NASDAQ:TRVN) reported positive top-line report from its Phase III APOLLO-2 and APOLLO-1 pivotal efficacy trials of oliceridine in acute pain following abdominoplasty and bunionectomy, respectively. In both trials, all dose regimens recorded their primary objective of statistically greater analgesic effectiveness than placebo, as noted by responder rate.
Moreover, oliceridine demonstrated dose-related trends of progresses versus morphine on different measures of gastrointestinal tolerability and respiratory safety, both major unmet areas in acute pain management.
The buzz
Maxine Gowen, Ph.D., the Chief Executive Officer of Trevena, reported that they consider the report for all 3 dose plans will advance FDA nod of IV oliceridine with an extensive indication of management of acute pain. These successful studies cap a development plan that has shown steady differentiation of oliceridine from morphine in numerous clinical trials. The management look forward to filing a new drug application with an objective of bringing this unique product to patients.
Timothy Beard, M.D. reported that this report is exciting. It validates earlier report and demonstrate an improved tolerability and safety profile of oliceridine against morphine, with similar data across the two trials.
Both APOLLO studies were Phase 3, randomized, multicenter, placebo- and active-controlled and double-blind trials of oliceridine. The main objective of each trial was to assess the analgesic efficacy of oliceridine as against placebo. Secondary objectives comprised comparisons of safety, tolerability and efficacy of oliceridine to morphine.
Both trials comprised numerous measurements of vomiting and nausea, which occur in almost 30% of postoperative people and increase expenses to hospitals, as well as numerous measures of respiratory safety, which can result in grave and expensive risks to patient safety.
In the last trading session, the stock price of Trevena declined more than 40% to close the day at $4.27. After the recent decline, the market cap of company stands at $226.65 million.
