Xartemis XR (oxycodone and acetaminophen CR) / Mallinckrodt - LARVOL DELTA

Mallinckrodt's CEO discusses F1Q2014 results - Earnings call transcript (SeekingAlpha) - Anticipated decision on NDA submission for Xartemis XR from the FDA by end of this month; Anticipated NDA filing during H2 2014 for MNK-155; Anticipated generic launch for Exalgo 32 milligram dosage strength in May.

Anticipated generic launch • Anticipated NDA • Pain

Opioid development strategies in pediatrics to get FDA advisory panel help (Pink Sheet - Informa) - "While FDA has long required pediatric analgesic studies...advisory committees will offer recommendations on other designs that may bring a more successful result. Three of FDA’s advisory committees will come together to help the agency shore up its guidelines on pediatric opioid development..."

Regulatory • Demo Pain • Pain

Study of COV795 in subjects with osteoarthritis or chronic low back pain (clinicaltrials.gov) - P3, N=250; Active, not recruiting -> Recruiting

Enrollment open • Pain

Depomed earns $10 million milestone for FDA approval of Mallinckrodt's Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets (CII) (PRNewswire) - "Depomed...today announced that the U.S. Food and Drug Administration (FDA) approved Mallinckrodt plc's New Drug Application (NDA) for XARTEMIS™ XR...Extended-Release Tablets (CII), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate....The NDA approval triggers a $10 million milestone payment to Depomed under Depomed's license agreement with Mallinckrodt."

Financing • NDA • Pain

Intrathecal Morphine Versus Extended-Release Epidural Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion. (PubMed) - Anesth Analg - "There was no difference in total morphine consumption or time until first PCA demand between the EREM and IT morphine groups. EREM provides a longer duration of analgesia after posterior spinal fusion for scoliosis and may be associated with less opioid-induced pruritus."

Journal • Biosimilar • CNS Disorders • Depression • Pain

76 billion opioid pills: Newly released federal data unmasks the epidemic (The Washington Post) - "America’s largest drug companies saturated the country with 76 billion oxycodone and hydrocodone pain pills from 2006 through 2012 as the nation’s deadliest drug epidemic spun out of control, according to previously undisclosed company data released as part of the largest civil action in U.S. history. The information comes from a database maintained by the Drug Enforcement Administration that tracks the path of every single pain pill sold in the United States...Three companies manufactured 88 percent of the opioids:...Mallinckrodt; ­Actavis Pharma; and Par Pharmaceutical...Purdue Pharma, which the plaintiffs allege sparked the epidemic in the 1990s with its introduction of OxyContin...was ranked fourth among manufacturers with about 3 percent of the market."

Clinical