RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021

https://finance.yahoo.com/news/redhill-biopharma-presents-three-analyses-100000757.html

[url]- Two new analyses of Movantik® (naloxegol) data evaluated the safety and efficacy of Movantik in a subgroup of patients aged ≥ 65 years

- Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid dosages

- Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain[/url][tag]insert-text-here[/tag]

TEL AVIV, Israel and RALEIGH, N.C., Sept. 7, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced presentation at PAINWeek 2021 of three new analyses of Movantik® (naloxegol) Phase 3 study data demonstrating rapid onset of action and sustained and predictable improvement of key symptoms associated with opioid-induced constipation (OIC) in both a subgroup of patients aged ≥ 65 and across both low and high dose opioid therapy.

Two of the posters are dedicated to the subgroup of patients aged ≥ 65, with Movantik achieving significantly better response rates vs. placebo, with rapid onset of action and a higher proportion of subjects achieving spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) over the first 48 hours of treatment. Additional presented data also shows that naloxegol delivers similar rapid and sustained symptom improvement for patients, irrespective of the opioid dose they are prescribed, including at doses lower than 100 mg of morphine equivalent. The authors conclude that even with lower doses of morphine equivalent, clinicians should be diligent about treating these patients because they still are susceptible to OIC.

The three analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the placebo arms.

"With up to 90% of older patients receiving opioids to help cope with chronic pain, and up to 86% of them suffering from symptoms of OIC, these new analyses are particularly important in helping these patients achieve satisfactory control of their pain without the added burden of OIC. Older patients tend to be more susceptible to OIC due to comorbidities, polypharmacy, and reduced physical activity, and it is vital that they have access to therapies such as Movantik, that are shown to be effective in this challenging patient group." said Dr. Lynn Webster, Pain Researcher and Clinician and Senior Fellow at the Center of U.S. Policy.

"There has been a shift in clinical practice to try to reduce doses of opioids used to treat chronic pain. However, low dose opioid therapy can prove to be equally troublesome in terms of treatment-related constipation as higher doses and it is important that physicians are diligent in monitoring for signs of OIC," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "This new analysis showing Movantik's efficacy irrespective of opioid dose is equally important in supporting the clinical shift to low dose opioid therapy through the management of OIC which can be expected in between 40-80% of patients taking chronic opioid therapy[1]."

New Movantik (Naloxegol) Analyses Presented at PAINWeek 2021:

Poster 1 (poster number 55):
Naloxegol Provided Rapid Onset of Time to First Spontaneous Bowel Movement (SBM), Complete SBM and Predictable Efficacy in Older Adults (Age ≥ 65 Yrs): A Pooled Analysis of Two Phase 3 Studies
Authors: Lynn Webster, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Martin Hale

Poster 2 (poster number 59):
Naloxegol Provided Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)
Symptoms in Older Adults Age ≥ 65 Yrs: A Pooled Analysis of Two Phase 3 Studies
Authors: Martin Hale, Charles Argoff, Charles H. McLeskey, Carol B. Rockett, Enoch Bortey, Theresa Mallick-Searle, Lynn Webster

Poster 3 (poster number 30):
Naloxegol Provides Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC)
Symptoms Irrespective of Opioid Dose: A Pooled Analysis of Two Phase 3 Studies
Authors: Jeffrey Gudin, Jeremy A. Adler, June Almenoff, Carol B. Rockett, Enoch Bortey, Richard Rauck, Lynn Webster