Drugs

Committees Support Pfizer’s Troxyca ER

Members of FDA’s Anesthetics and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Committee voted 9-6 on 6/8 to support the safety and efficacy of Pfizer’s NDA for Troxyca ER (oxycodone HCl and naltrexone HCl extended-release capsules). The company is seeking an indication for managing pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate.

Those supporting the chronic pain indication reportedly said that the company’s Phase 3 trial met the standard of approval set under the agency’s 505(b)(2) application pathway.

FDA staff explained to committee members that current regulations prevent it from refusing to approve an opioid analgesic based on a lack of abuse-deterrent properties. Many of the committee members voting in favor of the drug said they did not factor abuse-deterrence into their decision. A suggestion was made that the approval standards be reevaluated to reflect a growing desire to limit the number of long-acting/extended-release opioids available.

Those voting not to approve the drug cited concerns including the ease with which the oxycodone component may be extracted and separated from the naltrexone component; lack of clarity on the added value of the drug in terms of its abuse-deterrence; and a lack of evidence for efficacy of the entire opioid analgesic drug class in treating chronic pain.

Nine of the 15 committee members voted that Troxyca ER should not be labeled as an abuse-deterrent product by the oral route, given the concern about separating oxycodone from naltrexone and concern about whether the evidence of abuse-deterrence by the oral route meets appropriate labeling claim standards.

In other votes, 11 members said that Troxyca ER should be labeled as abuse-deterrent through the nasal route. And nine members voted that it should be labeled as abuse-deterrent by the intravenous route.

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