Pioneer Institute study finds IRA discourages non-opioid drug innovation

2024-04-26

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Pioneer Institute study finds IRA discourages non-opioid drug innovation

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来源: Pharmaceutical Technology

According to a report on GlobalData’s Pharma Intelligence Center, there were 1,038,938 diagnosed cases of opioid use disorder in the US in 2022. Credit: Tim Gray via Shutterstock

A study from a US-based public policy research firm has highlighted that the US Inflation Reduction Act (IRA) is likely to stifle research efforts into non-opioid pain medications.

The ongoing opioid crisis in the US demands alternatives to addictive pain medications. Several pharma companies have been accused of fuelling the opioid crisis by downplaying the addiction risks of their prescription pain drugs, contributing to the out-of-control opioid addiction problem in many American cities. The majority of heroin and fentanyl addictions stem from initial use of prescription drugs.

According to a report on GlobalData’s Pharma Intelligence Center, there were 1,038,938 diagnosed cases of opioid use disorder in the US in 2022. This number is expected to increase to 1,062,610 in 2027.

Introduced in 2022, the IRA allows Medicare to negotiate prices and rebates for certain drugs from drug makers in a pursuit to curb inflation. Critics have said the IRA may discourage research into small molecule drugs by imposing price controls four years earlier compared to biologics, significantly reducing the return-on-investment for pharma companies. Due to this, it is suggested that venture funds and biopharmaceutical companies will pull back from small molecule research. Most potential replacements for opioids fall into the small molecule category.

Co-author of the Pioneer Institute report Robert Popovian said: “If the pipeline for non-opioid pain therapies were robust, strategies like higher reimbursement rates could be effective. But the inability to achieve sufficient return on investment makes the existence of a robust pipeline highly unlikely.”

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Pain medication research has always been a difficult area to tackle. The report highlighted a 2023 Biotechnology Industry Organization (BIO) study, which found that pain projects have only a 0.7% probability of gaining US Food and Drug Administration (FDA) approval, compared to 6.5% across all diseases. It has been suggested that the IRA may further exacerbate this problem.

Movement in the non-opioid pain drug space

Still, some updates continue to happen in the the pain medication space. Earlier this month, Vertex Pharmaceuticals announced its plans to submit a new drug application (NDA) to the FDA after the Phase III programme investigating its non-opioid pain drug VX-548 met its primary endpoint.

However, the treatment did not achieve the secondary endpoints of reducing pain when compared to a combination of the opioid drug hydrocodone and acetaminophen. This means the Vertex pill did not prove more effective at reducing pain than traditional opioids.

The Pioneer report concludes with a harrowing statement: “Left unchecked, the IRA was probably the final nail in the coffin for small-molecule non-opioid replacement therapies.”

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