Scienza e Tecnologia
RedHill Biopharma Presents Three New Analyses of Movantik Data at PAINWeek 2021
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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." .
"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," . "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]."
Authors: Lynn Webster , Charles Argoff , Charles H. McLeskey , Carol B. Rockett , Enoch Bortey , Theresa Mallick-Searle , Martin Hale
Authors: Martin Hale , Charles Argoff , Charles H. McLeskey , Carol B. Rockett , Enoch Bortey , Theresa Mallick-Searle , Lynn Webster
Authors: Jeffrey Gudin , Jeremy A. Adler , June Almenoff , Carol B. Rockett , Enoch Bortey , Richard Rauck , Lynn Webster
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, for opioid-induced constipation in adults , for the treatment of infection in adults , and for the treatment of travelers' diarrhea in adults . RedHill's key clinical late-stage development programs include: (i) , with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) , a first in class oral SK2 selective inhibitor targeting multiple indications with a global Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) ( ), an oral serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) , with positive results from a first Phase 3 study for Crohn's disease; (v) , with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) - , an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.
Movantik® is an opioid antagonist indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Movantik (naloxegol) is contraindicated in:
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (e.g., multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.
Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.
Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Postmarketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).
Movantik (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Click here for the Medication Guide and full Prescribing Information for Movantik.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
MOVANTIK is a registered trademark of the AstraZeneca group of companies.
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Bryan Gibbs, Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
Amber Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
[1] Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.
[2] Full prescribing information for Movantik (naloxegol) is available at: www.Movantik.com.
[3] Full prescribing information for Talicia (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
[4] Full prescribing information for Aemcolo (rifamycin) is available at: www.Aemcolo.com.
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