Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain and
immuno-inflammatory diseases, today announced that the U.S. Food and
Drug Administration (FDA) has approved the supplemental new drug
application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien
plc, for the 32 mg dose strength of EXALGO® (hydromorphone HCl)
Extended-Release Tablets (CII), for the management of moderate to severe
pain in opioid-tolerant patients requiring continuous, around-the-clock
opioid analgesia for an extended period of time.
"More than one hundred million Americans suffer from
debilitating chronic pain that negatively impacts their quality of life;
including their ability to work, attend school and care for their
families," commented Mark H.N. Corrigan, MD, President and CEO of
Zalicus. "By providing a variety of tablet strengths of EXALGO,
physicians and patients can work together to develop and tailor a
treatment regimen that optimally controls their pain."
The rights to EXALGO were acquired by Mallinckrodt LLC, the
pharmaceuticals business of Covidien plc, in June 2009 for $15 million
in upfront payments, additional development funding of up to $16 million
and a $40 million FDA approval milestone payment. Zalicus receives
tiered royalties on net sales of EXALGO by Mallinckrodt.
The FDA approved the three existing doses of EXALGO (8, 12 and 16 mg) in
March 2010. Mallinckrodt subsequently submitted the sNDA in January 2012
with post-marketing data to support the original application's
compendium of clinical trials demonstrating safety, efficacy and
tolerability. Using OROS® technology, EXALGO provides a
steady release of hydromorphone throughout the day once steady-state is
achieved after three to four days. Additionally, EXALGO has physical
properties that may make it difficult to extract the active ingredient
using common forms of physical and chemical tampering, including
chewing, crushing and dissolving.
All EXALGO dosage strengths, including the new 32mg tablet which will be
available soon, are subject to the recently approved Risk Evaluation and
Mitigation Strategy (REMS) program for all long-acting and
extended-release opioids. The three primary components of this REMS
program are: training for prescribers in the form of continuing medical
education (CME) initiatives, which will be available by March 2013;
updated medication guides for each opioid and a patient counseling
document; and assessment and auditing to ensure the reach and
effectiveness of prescriber training.
In order to ensure a smooth transition to the class-wide REMS program,
Mallinckrodt will maintain the current EXALGO REMS program web site at www.exalgorems.com
and continue to provide important EXALGO prescribing information, with a
focus on appropriate patient selection and dosing, to new prescribers.