33. Olinvyk

FDA Building
Olinvyk faced a bumpy road to approval, with the original NDA filed in 2017. (FDA)

Active ingredient: Oliceridine
Disease: IV opioid for short-term use
Peak sales estimate: $300 million to $400 million
Approved: Aug. 7
Company: Trevena

The scoop: A low-key, narrow-focus launch for Trevena’s first drug approval set the tone as the newcomer looks to navigate the politics of marketing a new opioid product. The plan? Target healthcare professionals in acute care settings and focus on complex patient types such as elderly, obese and renally impaired patients. The short-term pain med administered only in-patient received its expected Schedule II Drug Enforcement Administration assignment in October and rolled out in November. Trevena plans a range of digital, virtual, on-demand and in-person channels to reach key healthcare professionals. Cantor labeled Olinvyk as “clinically differentiated” among medically supervised opioids in part simply “by the fact the company was able to get the product approved in the current environment.” Cantor estimates the total addressable market for Olinvyk at around $5 billion. However, with generic IV opioids taking a large share of that market, it put Olinvyk’s estimated peak sales at $300 million to $400 million. The drug faced a bumpy road to approval, with the original NDA filed in 2017. It was rejected in 2018 with the FDA pointing to inadequate safety data. Trevena refiled in February with additional safety and clinical data and an FDA-requested specified maximum dosage. – Beth Snyder Bulik

33. Olinvyk