On Thursday, PainReform Ltd. (NASDAQ: PRFX) experienced a shift in stock rating as Maxim Group adjusted its outlook from Buy to Hold. The decision came after the U.S. Food and Drug Administration (FDA) approved the first generic version of Exparel, a leading non-opioid post-operative pain analgesic. This approval on July 11, 2024, introduced a new competitor to the market dominated by Exparel, which reported sales of approximately $538 million in 2023.
Exparel, produced by Pacira Pharmaceuticals (NASDAQ: NASDAQ:PCRX), now contends with not only a generic alternative but also Heron Therapeutics' (NASDAQ: NASDAQ:HRTX) branded therapy, Zynrelef, which amassed $17.7 million in sales the previous year. PainReform's product, PRF-110, is in development to compete in this space, aiming to offer pain relief over 72 hours—a duration that surpasses Exparel's 24-hour relief but is on par with Zynrelef.
The Phase 3 trial for PRF-110 is designed to evaluate extended pain relief, yet it does not focus on measuring opioid sparing for labeling purposes. This particular aspect could have set PRF-110 apart in the market, especially now that a generic version of Exparel is available. The ability to reduce opioid use is considered a significant competitive edge in the industry.
Furthermore, the landscape of post-operative pain management might face additional shifts with the potential market entry of Vertex Pharmaceuticals' (NASDAQ: NASDAQ:VRTX) oral therapy in 2025. This could introduce another layer of competition for PainReform's PRF-110, as companies vie for a share of the post-op pain management market.
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