Drugs

Rolling NDA Filed for OTC Opioid Overdose

Harm Reduction Therapeutics (HRT) has begun a rolling NDA for RiVive (3 mg intranasal naloxone), indicated as an over-the-counter emergency treatment for opioid overdose. In July, FDA agreed to the company’s rolling review proposal after it granted the company fast track status, according to HRT.

HRT describes itself as a 501(c)(3) nonprofit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter (OTC) naloxone available to everyone. It says the prescription status and high cost of naloxone products “continues to limit access to this life–saving drug.”

The submission will be based on data from HRT’s nonclinical program and a pivotal bioavailability study “demonstrating that RiVive produced a 3-fold higher systemic exposure with comparable early absorption to the reference naloxone product,” the company says. “Moreover, our human factors validation study demonstrated that laypeople were able to administer RiVive in a simulated emergency overdose situation supporting that it will be appropriately used as an OTC product by the vast majority of people who need to administer it to victims of opioid overdose in order to save lives.”

Additionally, HRT says it has entered into a commercial supply agreement with a contract manufacturer in anticipation of FDA approval and U.S. launch in early 2024.

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