Drugs

Collegium Pharma Files sNDA on Xtampza

Collegium Pharmaceutical has submitted a supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment. The sNDA includes comparative oral pharmacokinetic data from a recently completed clinical study evaluating the effect of physical manipulation by crushing Xtampza ER compared with the abuse-deterrent version of OxyContin (oxycodone hydrochloride extended-release tablets) and a control (oxycodone hydrochloride immediate-release).

“The results for Xtampza ER, consistent with the data included in Xtampza ER prescribing information, demonstrated that crushing Xtampza ER prior to oral administration did not significantly affect its drug release profile,” Collegium says. The submission also includes an amendment to the Xtampza ER prescribing information to include comparative pharmacokinetic data for intact and crushed OxyContin alongside the data for intact and crushed Xtampza ER. Although Xtampza ER has abuse-deterrent properties, abuse by injection, nasal and oral route is still possible, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome