Drugs

FDA Approves Axsome’s Migraine Drug

FDA has approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. Approval was based on data from the Phase 3 MOMENTUM trial which treated moderate and severe migraine pain, the Phase 3 INTERCEPT trial which treated mild migraine pain, and the Phase 3 MOVEMENT long-term open-label safety trial, according to the company.

The trial data demonstrated a statistically significantly greater percentage of patients on Symbravo achieved pain freedom and freedom from their most bothersome symptom (photophobia, phonophobia, nausea) two hours after dosing compared to placebo, Axsome says. The drug also “demonstrated statistical superiority for pain relief (reduction of moderate or severe pain to no pain or mild pain) and the ability to perform normal daily activities,” it says. Regarding safety, the most common adverse reactions observed were somnolence and dizziness.

The company says Symbravo is engineered with Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) rapid absorption technology. “MoSEIC results in a five times faster median time to maximum plasma concentration for meloxicam while maintaining a long plasma half-life, enabling meloxicam’s use as a new molecular entity for the acute treatment of migraine,” 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