Data on vocacapsaicin suggest significant post-surgery pain relief, preventative of opioid dependency. Image: Shutterstock / FGC.

California-based biopharmaceutical company Concentric Analgesics announced they will present data today (6 August) on their novel pain management drug vocacapsaicin, highlighting pain relief and early opioid cessation.

The poster presentation, to be given at the International Association for the Study of Pain (IASP) World Congress in Amsterdam, NL, includes new Phase II data on opioid cessation with vocacapsaicin following total knee arthroplasty (TKA) (NCT03731364). The trial found that two weeks following TKA, 38% of patients receiving the drug required opioid-based analgesia compared to 58% of patients in the placebo group.

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CEO Frank Bellizzi told Pharmaceutical Technology that Concentric has a further, “four clinical studies” planned for vocacapsaicin, and that, “the first three studies have been cleared by the FDA.” He added that Concentric is “currently seeking to forge commercial partnerships.”

Also included in today’s presentation will be data from a Phase II trial investigating vocacapsaicin following bunionectomy (NCT03599089). These data, published in Anesthesiology, demonstrated that vocacapsaicin enabled opioid use cessation by 5 days post-surgery for all patients; this was achieved by only 16% of patients receiving placebo, half of whom continued opioid use at two weeks.

This data is significant given the US’s opioid epidemic. The risk of persistent opioid use which can lead to addiction increases most significantly once use continues past 5 days. “The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks”, according to Edwin Su, MD, from Weill Cornell Medical College.

Vocacapsaicin is a prodrug of capsaicin which releases its product locally. It triggers TRPV1 receptors on pain-specific nerves to induce long-lasting analgesia. Vocacapsaicin’s effects can last months without numbness or motor weakness. Harold Minkowitz, MD, from HD Research, notes “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia.”

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Vocacapsaicin received Fast Track designation from the US Food and Drug Administration (FDA) in 2017 and Breakthrough Therapy designation in 2018. In 2019, Concentric raised $76mn in Series B financing, and has raised $40mn in the past three years, as per GlobalData.

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The drug could benefit from the Non-Opioids Prevent Addition in the Nations (NO PAIN) Act passed by the US congress and set to go into effect in January 2025. This would increase access to non-opioid pain management by removing reimbursement barriers for Medicare.