Drugs

FDA Priority Review for KemPharm Pain Drug

FDA has accepted for priority review a KemPharm NDA for KP201/APAP, its investigational drug candidate for the short-term management of acute pain. The agency has set a user fee review action date of 6/9. The immediate release combination of KemPharm's prodrug of hydrocodone, KP201 (benzhydrocodone hydrochloride), and acetaminophen was developed to deter certain common methods of abuse and may also limit excessive opioid exposure in patients and non-medical users compared to currently available hydrocodone combination products, the company says.

The submission requests that FDA recommend that the product be classified as a Schedule III controlled substance. This request is based on the reduced potential for abuse and the potential safety features attributable to lower exposure levels to hydrocodone as compared to other hydrocodone products, which are designated as Schedule II, according to the company.

KemPharm says it developed KP201/APAP using its proprietary Ligand-Activated Technology (LAT), 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