Drugs

Collegium Wants Oxycodone ER Restrictions

Collegium Pharmaceutical is petitioning FDA not to approve any pending NDA for an extended-release (ER) oxycodone drug product, including Pain Therapeutics’ NDA for Remoxy ER, unless the product (1) bears abuse-deterrent labeling based on premarket studies conducted in each of the three categories in FDA’s 4/2015 guidance on abuse-deterrent opioids, and (2) demonstrates abuse-deterrence that is at least equivalent to or superior to approved ER oxycodone drug products for all routes of abuse such as Collegium’s Xtampza ER extended-release capsules.

Specifically, the petition asks that the agency:

apply existing standards for laboratory-based in vitro manipulation and extraction studies, including physical manipulation and both small and large volume extraction, before approving any opioid drug product with potentially abuse-deterrent properties, including Pain Therapeutics’ pending 505(b)(2) NDA for Remoxy ER; and
· require that all oxycodone ER products currently labeled as abuse-deterrent be required to meet current standards set forth in the Abuse-Deterrence Guidance for Class 1, 2, and 3 data, or have their abuse-deterrent labeling removed (and, if appropriate, approval rescinded) within a reasonable period of time (not to exceed six months).

The petition says that Purdue Pharma’s OxyContin extended-release tablets cannot meet the standards and FDA should take immediate action to revoke the abuse-deterrent labeling approved for OxyContin and reconsider if the benefits of the drug continue to outweigh the risks.

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