Drugs

FDA Denies Petition Seeking ‘Optimal’ Naloxone Dose

FDA has denied a citizen petition from Adapt, the manufacturer of Narcan (naloxone) Nasal Spray, 4 mg, indicated for treating opioid overdose, asking that it publish a guidance for all naloxone products to identify the “optimal fixed initial dose for each route of administration as well as the required exposure levels to achieve an efficacious onset of action and duration of effect.” In the petition, the company argued that there has been “an acceleration of expanded naloxone access to new potential witnesses and more potent and faster onset opioids (e.g., fentanyl) being implicated in a growing proportion of opioid overdose deaths. These provide an urgent need to ensure that new naloxone formulations intended for emergency treatment in all settings, (including non-medical settings), by anyone (including non-medically trained individuals), deliver a consistently efficacious fixed initial dose that achieves optimal exposures to naloxone (i.e. plasma levels) and can be easily and rapidly administered.”

The petition says that before approving new naloxone, the agency should define the required pharmacokinetic exposure levels for naloxone that are required to be achieved from the recommended optimal dose of naloxone, including time to onset and duration of effect. And it requests that FDA require “naloxone products from an applicant to utilize a product formulation and device that allows for an individual, (including a non-medically trained individual) in all settings, (including non-medical settings), to readily and rapidly administer a fixed initial dose.”

In denying the petition, FDA disagreed with the company’s contentions that an optimal fixed dose of naloxone for each route of administration should be specified. “Two naloxone products with the same nominal dose but different formulations could produce substantially different naloxone exposure levels depending on how quickly and how much of the naloxone is absorbed,” the agency said. “Those rates may be significantly affected by the specific formulation, including the nature and amounts of inactive ingredients. In addition, each application will be evaluated will be evaluated taking into account the relevant standards for approval.”

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