TRVN) announced that Olinvyk (oliceridine), the company’s opioid agonist, finally received the FDA’s nod of approval for the management of acute pain in adults who need an intravenous opioid pain reliever. The drug is to be administered in hospitals or other controlled clinical settings.” data-reactid=”12″>There’s a new FDA-approved pain medication on the scene. On Monday, Trevena (TRVN) announced that Olinvyk (oliceridine), the company’s opioid agonist, finally received the FDA’s nod of approval for the management of acute pain in adults who need an intravenous opioid pain reliever. The drug is to be administered in hospitals or other controlled clinical settings.
The approval brings to an end a process stretching back to 2018, when Trevena received the dreaded complete response letter (CRL) from the FDA, citing concerns regarding the size of the safety database and potential for QT prolongation.
Douglas Tsao calls the approval a “big win for Trevena.” Trevena will launch Olinvyk in Q4 and Tsao anticipates the approval will act as a catalyst for several of Trevena’s ex-US partners “to provide critical non-dilutive capital in the form of milestone payments.”” data-reactid=”14″>H.C. Wainwright analyst Douglas Tsao calls the approval a “big win for Trevena.” Trevena will launch Olinvyk in Q4 and Tsao anticipates the approval will act as a catalyst for several of Trevena’s ex-US partners “to provide critical non-dilutive capital in the form of milestone payments.”
Even though the analyst expects initial adoption to take place amongst high-risk patients, Tsao believes the drug will get more widespread use eventually. Additionally, the label’s lack of restrictive language such as “moderate-to-severe acute pain” will provide Trevena with “leeway to promote the product for a wide range of surgical procedures.”
Furthermore, Tsao argues Olinvyk’s distinctive properties sets it apart from other drugs.
“Though the drug was shown to be as fast and effective as IV morphine in treating post-surgical pain,” Taso noted, “its unique mechanism of action that bypasses the β-arrestin pathway, improves the drug’s respiratory safety and gastrointestinal tolerability. These features are important differentiators versus traditional opioids.”
The analyst anticipates peak US sales of $284 million, although he “would not be surprised to see upside,” and following the approval, increases the probability of success for Olinvyk to 100%.
click here)” data-reactid=”23″>The confidence is rewarded with a price target boost to boot. The figure moves from $4 to $5 and represents possible upside of 60% over the coming months. To this end, the analyst’s Buy rating stays as is. (To watch Tsao’s track record, click here)
See Trevena stock analysis on TipRanks)” data-reactid=”24″>Though not many have weighed in with an opinion on Trevena, those who have are singing its praises loudly. Overall, two analysts rate the drug maker a Buy. Meanwhile, the average price target stands tall at $5.50, suggesting the stock could double over the next 12 months. (See Trevena stock analysis on TipRanks)
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