Trevena notched its first drug approval last week with intravenous opioid Olinvyk. Now comes the tricky part—navigating the politics of marketing a new opioid product.
To do that, Trevena plans to take a narrowly focused approach, targeting healthcare professionals in acute care settings with a focus on complex patient types including elderly, obese and renally impaired people.
Trevena plans to deploy its sales team initially to call on select accounts that look to have good potential for adoption, a spokesperson said via email.
Sales rep training, compliance and monitoring programs are also in place to ensure marketing sticks to FDA guidelines. Trevena will look to use a range of digital, virtual, on-demand and in-person channels to reach HCPs, the company said.
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“Our goal is not to expand overall opioid use; rather, we intend for Olinvyk to be used where injectable opioids are already being used in controlled clinical setting,” the spokesperson added.
While Trevena is limited by Olinvyk’s approval only for short-term IV use in hospitals or other controlled clinical settings, it’s facing the additional hurdle of the opioid addiction crisis. The FDA addressed the crisis in a news release about the approval of Olinvyk, highlighting that the new drug can only be used in clinical settings under medical supervision.
“Addressing the opioid crisis remains a top priority for the FDA,” said Doug Throckmorton, deputy director for regulatory programs, adding that “the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness.”
Olinvyk is classified as a schedule IV drug, ranked by the FDA as low potential for abuse and low risk for addiction, but the opioid moniker carries baggage.
As the opioid addiction crisis continues and the FDA works to help stem it, drugmakers who were sued for hundreds of millions by city and state governments over marketing claims continue to settle. The results are massive billion-dollar payouts, often followed by bankruptcy proceedings.
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Trevena will launch Olinvyk this fall after its 90-day scheduling by the U.S. Drug Enforcement Agency (DEA).
The drug faced a bumpy road to approval. Originally named Olinvo, Trevena first filed a new drug application in 2017. However, the drug was rejected in 2018 with the FDA pointing to inadequate safety data. The review panel also noted the drug’s potential for abuse and overdose, similar to that of other opioids.
Trevena refiled in February with additional safety and clinical data, along with an FDA-requested specified maximum dosage.
