Drugs

Reviewers See Oliceridine Abuse, Overdose Potential

FDA medical reviewers are raising safety concerns about Trevena’s next generation opioid oliceridine injection, for which the company is seeking an indication for managing moderate-to-severe pain in adult patients for whom an intravenous opioid is warranted. The Trevena NDA will be considered by the agency’s Anesthetic and Analgesic Drug Products Advisory Committee at its 10/11 meeting.

A briefing document distributed in advance of the meeting says the company hypothesizes that the mechanism of action of the G protein-based ligand will result in less respiratory depression, less slowing of gastrointestinal motility, and less sedation compared with morphine.

Medical reviewers tell committee members that their overall assessment of abuse-related data from clinical studies leads to the finding that oliceridine has an abuse potential, overdose potential, and ability to produce physical dependence that is similar to other such treatments.

Committee members are being asked to comment on the drug’s efficacy and safety for the proposed indication, oliceridine’s abuse potential, concerns about the drug’s impact on public health, and whether they recommend approval.

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