Data to Feature New Health Economic Outcomes Research of Treatment of Emergency Department Patients with Opioid-Induced Constipation - Bausch Health Companies Inc. and its gastroenterology business, Salix Pharmaceuticals, one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, today announced that new Health Economic Outcomes ...

Data to Feature New Health Economic Outcomes Research of Treatment of Emergency Department Patients with Opioid-Induced Constipation

- Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals, ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, today announced that new Health Economic Outcomes Research (HEOR) data featuring RELISTOR® (methylnaltrexone bromide) will be shared at PAINWeek 2021 taking place in Las Vegas from Sept. 7-11, 2021 .

"We look forward to PAINWeek where we will share new HEOR data regarding the use of RELISTOR, which is approved for the treatment of opioid-induced constipation, in the hospital emergency department setting. The three abstracts presented at PAINWeek represent the broad utilization of RELISTOR in the various settings of care in which OIC patients visit," said Robert Spurr , president, Salix Pharmaceuticals.

The following abstracts are available online via the PAINWeek website , and the corresponding scientific posters will be displayed in the exhibit hall at The Cosmopolitan of Las Vegas from Sept. 8-10, 2021 :

  • Peacock, Frank et al. "Approved OIC medication use in emergency department patients with opioid-induced constipation."
  • Shah, Eric et al. "Repeat dosing with subcutaneous methylnaltrexone: a pooled analysis of up to 7 doses in patients with and without cancer."
  • Tong Yu, Qi et al. "Subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation and the impact of baseline osmotic and stimulant laxative use."

About RELISTOR
RELISTOR® (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults 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.

RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

IMPORTANT SAFETY INFORMATION

  • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
  • Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
  • If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their health care provider.
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
  • Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
  • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
  • A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child- Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.
  • In the clinical studies, the most common adverse reactions were:
    OIC in adult patients with chronic non-cancer pain
    • RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
    • RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).
  • OIC in adult patients with advanced illness
    • RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

About Salix
Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey . For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn .

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn .

Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health Companies Inc.'s (Bausch Health) most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration, and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

©2021 Salix Pharmaceuticals or its affiliates.
RELISTOR is a trademark of Salix Pharmaceuticals or its affiliates.
SAL.0113.USA.21

Investor Contact:

Media Contact:

Arthur Shannon

Lainie Keller

arthur.shannon@bauschhealth.com

lainie.keller@bauschhealth.com

(514) 856-3855

(908) 927-1198

(877) 281-6642 (toll free)


Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/salix-will-share-relistor-methylnaltrexone-bromide-data-at-painweek-2021-301368004.html

SOURCE Bausch Health Companies Inc.

News Provided by PR Newswire via QuoteMedia

Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests

- Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today confirmed that its polymerase chain reaction (PCR) TaqPath COVID-19 Combo Kit *, and TaqPath COVID-19 CE-IVD RT-PCR Kit *, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results.

The Omicron variant, which was designated a " variant of concern " by the World Health Organization (WHO), has more than 30 mutations in the spike protein alone. The WHO has reported that preliminary evidence suggests an increased risk of transmission compared to other variants of concern. This designation and information are leading to renewed travel restrictions and research to examine the variant's impact on efficacy of existing vaccines and tests. The WHO and European Centers for Disease Control have both reported that using S-gene target failure (SGTF) of the PCR assays as a proxy for the variant helped to identify Omicron. Cases of the variant were first identified in South Africa and have now been reported in at least a dozen countries around the world.

Keep reading... Show less
UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical

UPDATED - Leveljump Healthcare Corp. Announces 14.6% Minority Investment in Real Time Medical

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, subject to regulatory approval, it has agreed to acquire an outstanding 14.6% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 2,494,576 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.66 per Unit with each Unit being comprised of three (3) Leveljump common shares at a deemed price of $0.22 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

The equity interest in RTM was acquired through a mini-tender offer to the shareholders of RTM dated November 1, 2021 whereby JUMP offered to acquire up to 19.9% of RTM in exchange for the Units. The holders of the RTM shares who have tendered are all accredited investors.

Keep reading... Show less
Leveljump Healthcare Corp. Announces $3.2 Million Term Loan Commitment from TD Canada Trust

Leveljump Healthcare Corp. Announces $3.2 Million Term Loan Commitment from TD Canada Trust

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that it has secured a term loan commitment from TD Canada Trust for $3.2 million for the purpose of closing the Company's previously announced acquisition of three Ontario Diagnostic Imaging Clinics (Press release September 28, 2021).

Combined with the Company's cash on hand, the term loan will allow the Company to close the Ontario Diagnostic Imaging Clinics acquisition.

Keep reading... Show less
Leveljump Healthcare Corp. Announces 13.1% Minority Investment in Real Time Medical

Leveljump Healthcare Corp. Announces 13.1% Minority Investment in Real Time Medical

LevelJump Healthcare Corp. (TSXV: JUMP) (OTCQB: JMPHF) (FSE: 75J) ("Leveljump" or the "Company"), a Canadian leader in B2B telehealth solutions, is pleased to announce that, subject to regulatory approval, it has agreed to acquire an outstanding 13.1% minority equity interest in Real Time Medical Inc. ("RTM"), a private Ontario company, in exchange for 2,244,576 units (a "Unit") of Leveljump. Each Unit will be issued at a price of $0.66 per Unit with each Unit being comprised of three (3) Leveljump common shares at a deemed price of $0.22 per share and one (1) share purchase warrant of Leveljump, each warrant entitling the holder to acquire one additional common share of Leveljump at a price of $0.35 per common share on or before December 31, 2023.

The equity interest in RTM was acquired through a mini-tender offer to the shareholders of RTM dated November 1, 2021 whereby JUMP offered to acquire up to 19.9% of RTM in exchange for the Units. The holders of the RTM shares who have tendered are all accredited investors.

Keep reading... Show less
HealthTab to Offer Abbott's i-STAT Alinity, Expanding Chronic Disease Testing to Select Community Pharmacies in Canada

HealthTab to Offer Abbott's i-STAT Alinity, Expanding Chronic Disease Testing to Select Community Pharmacies in Canada

Avricore Health Inc. (TSXV: AVCR, OTC: AVCRF) ("Avricore Health" or the "Company") is pleased to announce the signing of a non-exclusive, pilot supplier distribution agreement in Canada between HealthTab™ Inc., a wholly owned subsidiary, and Abbott, the global healthcare company, with respect to the handheld blood chemistry analyzer, i-STAT Alinity.

The agreement allows HealthTab to distribute Abbott's point-of-care i-STAT Alinity and its associated tests for creatinine in Canadian pharmacies to better support patients with important information about their renal function.

Keep reading... Show less

Medtronic Reports Second Quarter Fiscal 2022 Financial Results

- Medtronic plc (NYSE:MDT) today announced financial results for its second quarter of fiscal year 2022, which ended October 29, 2021 .

Keep reading... Show less

Top News

Related News