oxycodone ER (Egalet-002) / Assertio - LARVOL DELTA

Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain (clinicaltrials.gov) - P3; N=281; Active, not recruiting; Sponsor: Egalet Ltd; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Demo Pain • Oncology • Pain

Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain (clinicaltrials.gov) - P3; N=250; Not yet recruiting; Sponsor: Egalet Ltd

New P3 trial • Biosimilar • Oncology • Pain

Egalet: FDA approval boost on the way? (SeekingAlpha) - "EGALET 002...Phase/Status/Expected Launch: In Phase III trials, with the potential to file an NDA late in 2016 or early 2017."

Anticipated NDA • Demo Pain • Pain

FDA approves cocaine nasal spray (Pain News Network) - "FDA advisory committees have taken a dim view of opioid medications recently, soundly rejecting new drug applications for the 'opioid of the future' oxycodegol and a new extended-release version of oxycodone."

FDA event

Doctors can change opioid prescribing habits, but progress comes in small doses (Fierce Health Care) - "When they started practicing medicine, most surgeons say, there was little or no information about just how many pain pills patients needed after specific procedures...'There is a misconception that this is all fixed,' said Chad Brummett...and one of the researchers on this study. 'I do think people are still overprescribing. Definitely.' The guidelines come amid ongoing concern about the opioid crisis and a continued examination of the role prescription drugs played in its escalation."

Media quote

New details about Michigan’s opioid crisis: Billions of pills and aggressive suppliers (MLive) - "The federal data 'confirms what we already knew, that billions of pills were flooding our streets,' said Dr. Chad Brummett...What did change, he said, was change in attitude in the medical community that patient-centered care required clinicians to take complaints about pain more seriously. Drugmakers leveraged that into aggressive marketing of opioid painkillers, Brummett said, 'overplaying their benefits and downplaying their addictive qualities.'"

Media quote

Intellipharmaceutics International Inc. announces update on its oxycodone ER New Drug Application (Intellipharmaceutics Press Release) - "Intellipharmaceutics International Inc....announced today that it has been advised by the U.S. Food and Drug Administration’s ('FDA') that the FDA 'is postponing product-specific advisory committee meetings for opioid analgesics,' including the one previously scheduled to discuss the Intellipharmaceutics New Drug Applications ('NDA')...The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act ('PDUFA') timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019."

NDA • PDUFA date