Drugs

Aquestive Therapeutics Asks Approval Stay for Valtoco

Aquestive Therapeutics, which is testing Libervant (diazepam) buccal oral film for seizure clusters, is asking FDA to stay approval of Neurelis’ 505(b)(2) NDA for Valtoco (diazepam intranasal solution) until additional clinical studies have been conducted that would allow for adequate labeling as requested by Aquestive. An Aquestive 11/1 petition says the additional requested studies including a bridging study comparing Valtoco to Diastat (diazepam rectal gel) in patients taking anti-epileptic drugs demonstrating comparable exposure, and a food effect study for Valtoco in patients. The company also requests that unless the additional clinical studies demonstrate otherwise, FDA determine that Valtoco does not offer a major contribution to patient care under the Orphan Drug Act.

The petition says that while Aquestive was developing Libervant, it learned that Neurelis was developing a nasal diazepam product. “Both Libervant and Valtoco have proposed indications for patients with epilepsy who experience bouts of increased seizure activity while on a stable regimen of daily antiepileptic medications,” the petition says. “While Aquestive conducted a patient crossover study of Libervant to Diastat to assure an adequate bridge to its reference, as well as food effect studies that will allow for adequate labeling, Neurelis has avoided conducting such studies. Aquestive believes that Neurelis should conduct such studies to fully characterize the risk of Valtoco and assure that adequate labeling be developed that will allow for safe use of the product in its intended patient population.”

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