On Thursday, PainReform Ltd. (NASDAQ: PRFX) experienced a shift in stock rating as Maxim (NASDAQ:MXIM) 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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