"We are honored to be presenting our CONFIRM abstract at AASLD," said
The CONFIRM clinical trial assessed the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 CONFIRM is the largest prospective trial ever conducted in this patient population. Mallinckrodt announced in August that the study met its primary endpoint of verified HRS-1 reversal (p=0.012). "Verified HRS-1 reversal" is a term denoting three components: renal function improvement, avoidance of dialysis and short-term survival.
The company plans to submit a New Drug Application to the
"HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S.2,3 annually. It is a rapidly progressing and devastating condition, and many patients don't live beyond a few weeks if left untreated,"4,5 said presenting author Florence Wong, MBBS, MD, FRACP, FRCPC, hepatologist at
HRS-1 has a very poor prognosis, with a median survival of less than two weeks and greater than 80 percent mortality within three months if left untreated.4,5 At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada.6
About the Pivotal Phase 3 CONFIRM Study (multi-center, randomized, placebo-controlled, double-blind trial in the U.S. and
Find out more information about the CONFIRM trial here on the ClinicalTrials.gov website.
Terlipressin is a potent, vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. Terlipressin is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to terlipressin and the study described in this release, including expectations with regard to future regulatory filings and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of
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© 2019 Mallinckrodt. US-1901869 10/19
2 C Pant, B S Jani, M Desai, A Deshpande,
3 US Census 2018 https://www.census.gov/search-results.html?searchType=web&cssp=SERP&q=US population 2018, accessed on
4 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy, Expert Review of Gastroenterology & Hepatology. (2018) 12:2, 173-188, DOI: 10.1080/17474124.2018.1417034.
5 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. (2018) 4:23.
6 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT.
7 Data on file.
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