RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma's Movantik® Added as Preferred and Unrestricted Brand To Major National Medicare Formulary Serving Millions of Americans

https://finance.yahoo.com/news/redhill-biopharmas-movantik-added-preferred-122200874.html

Movantik® approved for inclusion as preferred and unrestricted brand on a major National Medicare Part D formulary serving more than 10 million Americans as of January 1, 2022

Movantik's total commercial coverage extends to 152 million American patients' lives and will grow to 46 million Medicare lives and will increase to over 94% coverage of Medicare Part D lives

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

TEL AVIV, Israel and RALEIGH, N.C., Dec. 1, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that one of America's largest payors, serving more than 10 million Americans through multiple Medicare plans, has approved the inclusion of Movantik® (naloxegol), a peripherally acting mu-opioid receptor antagonist (PAMORA) for opioid-induced constipation, as a preferred and unrestricted brand on its National Medicare Part D formulary starting January 1, 2022.

"It is important for optimal chronic pain treatment that patients are able to manage the debilitating constipation that often accompanies opioid therapy and have access to treatments such as Movantik," said Rick Scruggs, RedHill's Chief Commercial Officer. "This important new listing for Movantik, the market-leading PAMORA for opioid-induced constipation, as a preferred and unrestricted brand on a major National Medicare Part D formulary provides that access to more than 10 million more Americans covered by this formulary. Movantik now has coverage of 90% of U.S. commercial lives and will increase to over 94% coverage of Medicare Part D lives, as we continue our efforts to increase patient access to Movantik."

About Movantik® (naloxegol)

Movantik® is an opioid antagonist 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.

Important Safety Information About Movantik

Movantik® (naloxegol) is contraindicated in:

Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.

Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.

Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

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.