FDA Roundup of the Week: November 4

NOVEMBER 04, 2017
Kevin Kunzmann
fda, opioids, opiates, scott gottlieb, xarelto, rivaroxiban, vte, buprenorphineIn a relatively slow week of drug rulings, the US Food and Drug Administration (FDA) has made more clear stances on issues surrounding the national opioid epidemic. Though more regulations and recommendations are expected to come from the federal level, the FDA’s intermittent efforts to stymie opioid abuse have been substantial in past months.

Catch up on all their news, and more, with MD Magazine’s FDA Roundup of the Week:

FDA Approves New 10 mg Dosing for XARELTO

XARELTO was approved for the reduction of continued risk of recurrent venous thromboembolism in patients who completed at least 6 months of initial anticoagulation therapy. It was initially given FDA priority review from its supplemental new drug application submitted back in April. The oral therapy met its primary efficacy endpoint in a previous 10mg and 20mg dosage trial, with both doses proving superior in reducing recurrent VTE risk versus aspirin.

Gottlieb Announces Possible FDA Strategies to Combat Opioid Crisis

FDA Commissioner Scott Gottlieb, MD, addressed strategies such as new prescription packaging measures, and improved monitoring technology to check patient drug use. Gottlieb also called for improved unused prescription disposal, saying that the 3 practices could have a “meaningful impact on preventing or deterring misuse, abuse, or inappropriate access to prescription opioids.”

FDA Advisory Committee Recommends RBP-6000 For Opioid Use

Indivior announced the investigational once-monthly injectable buprenorphine formulation received an 18-to-1 Psychopharmacologic Drugs Advisory Committee vote of support to treat opioid use disorder. The vote came shortly after Gottlieb announced intentions to encourage more use of less harmful opioids such as methadone and buprenorphine in opioid addicts.

RedHill Biopharma Submits NDA for New Rizatriptan Formula

The thin-film formulation of 10mg RIZAPORT is intended for acute migraine treatment. The new drug application submission is not RedHill’s first attempt — its 2013 NDA received a complete response letter in the following February due to concerns about third-party chemistry, manufacturing and control, and the labeling and packaging of the product.

 

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