ICS 2018: Novel Prolonged Action Formulation of Acetaminophenibuprofen Combination Paxerol® Therapy for Treatment of Nocturia: a Multi-Center, Randomized, Double Blinded, Placebo Controlled, 4 Arm Phase 2 Trial

Philadelphia, PA (UroToday.com)  Mahyar Kashan, MD has presented a study on Paxerol®, the novel combination drug for the treatment of nocturia. It contains two prostaglandin inhibitors, acetaminophen, and ibuprofen, which could potentially affect detrusor muscle activity and voiding patterns.

The research was conducted to evaluate overall safety and efficacy of new medication, assess the quality of life outcomes related to nocturia, examine the average number of voids per night and hours of sleep, and investigate effect of the drug on the first uninterrupted sleep period.

Subjects who reported nocturia, but didn’t have urinary tract infections, increased post residual volume (PVR), neurologic or sleep comorbidities were enrolled into 4 arms, double-blind, Phase 2 study. 80 patients have completed 2 weeks of treatment with low, medium, or large dose of Paxerol, or placebo.

The study showed that treatment groups had a statistically significant reduction in nocturic episodes compared to the placebo group (Figure 1).
UroToday ICS2018 study on Paxerol the novel combination drug for the treatment of nocturia 1
Figure 1

While there were no remarkable changes in the overall hours of sleep, subjects from the high dose group reported a significant increase in the first uninterrupted sleep period. In addition, all 4 groups showed an increase in nocturia-related quality of life (Figure 2)

UroToday ICS2018 study on Paxerol the novel combination drug for the treatment of nocturia 2
Figure 2

While trial had promising results, expert panel participants pointed out that it would be beneficial to evaluate long-term use of Paxerol since ibuprofen can lead to negative upper urinary tract outcomes.

Presented by: Mahyar Kashan, MD, Downstate College of Medicine, Brooklyn, NY
Co-authors: Khusid J A, Weiss J P, Rauscher F, Blair B, Efros M, Kaminesky J, Contreras J, Rydin I, Xie L, Whisnant J, Lee K

Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania, @PennUrology at the 2018 ICS International Continence Society Meeting - August 28 - 31, 2018 – Philadelphia, PA USA