Drugs

FDA Complete Response Letter on KemPharm’s Pain Drug

FDA has issued KemPharm a complete response letter for its NDA for Apadaz (benzhydrocodone and acetaminophen), an investigational abuse-deterrent product candidate for the short-term management of acute pain. The letter is in response to an NDA amendment that the company filed last week (see story) that seeks to strengthen the drug’s labeling related to its abuse-deterrent properties.

The amendment presumably addresses concerns expressed by members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee when they voted last month 16-4 to recommend approval for the drug. During the committee meeting, FDA asked the advisors to vote on whether data submitted by the company support a labeling claim that Apadaz is an abuse-deterrent product. On an 18-2 vote, committee members said Apadaz should not be labeled as abuse-deterrent. They acknowledged that the available data suggest the potential for a marginal benefit in preventing abuse via the intranasal route and encouraged the company to continue studying the drug’s abuse-deterrent properties to acquire data that in the future could reach the standards needed for a labeling claim.

KemPharm says it developed the drug using its proprietary Ligand-Activated Technology, which creates a new prodrug by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. “Once administered, human metabolic processes, such as those in the gastrointestinal tract, separate the ligand from the prodrug and release the parent drug, which can then provide its therapeutic effect,” 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