Drugs

FDA Approves Avanir NDA for Migraine Intranasal Drug

FDA has approved an Avanir Pharmaceuticals NDA for Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. The intranasal medication delivery system comprises a low-dose (22mg) of sumatriptan powder that is delivered utilizing the Xsail Breath Powered Delivery Device, according to the company.

The agency in 2014 issued a complete response letter on the NDA, raising questions about data from a human factor validation study contained in the submission. The company said at the time that the letter requested that Avanir assess the root causes of device use errors observed in the previously conducted human factors testing. “A new human factors validation study will be required to assess usability of the device following improvements,” it said, adding that the agency did not find any clinical or non-clinical safety or efficacy issues nor chemistry, manufacturing, and controls issues.

“The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels,” the company says. “By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”

Approval was based on clinical data involving over 300 patients, and reference data from clinical use of sumatriptan over the past 20 years. In the pivotal TARGET trial, the company says 230 migraine sufferers were randomized to self-administer either ONZETRA or placebo using the Xsail device when they had moderate to severe migraine pain. Study results demonstrated that a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes (41.7% vs. 26.9%) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%), 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