To date, Trevena Inc. (NASDAQ:TRVN) has five novel and differentiated investigational drug candidates under its sleeve. This does not mean that the company is not pursuing other treatments because it has received the approval of its OLINVYK from the FDA. OLINVYK is the first new chemical entity in this IV drug class in decades. It will be a treatment in adults managing acute pain severe, which requires an intravenous opioid analgesic.
The Approval Was Based On Data from 2 Pivotal Phase 3 Studies
The open-label, phase 3 study enrolled 790 adult patients who exhibited moderate to severe acute pain. This had to be from either orthopedic surgery-bunionectomy (APOLLO-1) or plastic surgery-abdominoplasty (APOLLO-2). The study evaluated the efficacy and safety of oliceridine administered in amounts of 0.1mg, 0.35mg, or 0.5mg vs. placebo or morphine.
There was a greater analgesic effect in the oliceridine 0.35mg and 0.5mg treatment compared to the placebo. This means the former was found tolerable and safe even in a medically complex patient population such as the elderly and obese patients. However, some adverse events included constipation, nausea, headache, dizziness, vomiting, and hypoxia.
Trevena’s Mission of Translating Cutting-Edge Scientific Discovery
The company’s CEO, Carrie L. Bourdow, is confident about the turnaround of events following the approval of OLINVYK. It will give them a wider scope of pursuing cutting-edge scientific therapeutic, which will benefit the more than 45 million hospital patients receiving an IV opioid in the United States.
“…We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options,” Bourdow explained.
There is a rising trend of patients with complex and postoperative acute pain to manage, which represents an increasing burden on the healthcare system and patients’ caregivers. The worst-hit are the elderly and those with comorbid conditions such as diabetes.
However, OLINVYK represents a new ray of hope. The company is awaiting the issuance of a controlled substance schedule from the Drug Enforcement Administration (DEA) before commercializing the treatment. This may take about 90 days, meaning it could into the Q4 2020.