Oxtellar XR Approved as Monotherapy, Pregnancy Safety Data for Betaseron, and Biologic Brain Changes in Migraine


Neurology News Network for the week of December 22, 2018.

This week, Neurology News Network covered the FDA's approval of oxcarbazepine extend-release for use as a monotherapy for partial-onset seizures, and the inclusion of safety data for women with multiple scleorsis who are pregnant to interferon-ß1b's prescribing information. Additionally, we spoke about NeurologyLive's newest episode from its "Chronic Migraine New Paradigms in Management" Peer Exchange series, which provides comment on defective interaction of systems during migraine. (Transcript below.)

Welcome to Neurology News Network. I’m Matt Hoffman. Let’s get into the news from this week.

The FDA has approved an sNDA for oxcarbazepine extended-release, marketed as Oxtellar XR by Supernus Pharmaceuticals, to expand the medication’s indication beyond the current one of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.

The treatment, now approved as a monotherapy, is the first novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients aged 6 years and older. It is available in 150-mg, 300-mg, and 600-mg extended-release tablets.

The Agency didn’t stop with Oxtellar’s expanded indication. It also approved the inclusion of new safety data on pregnancy in the prescribing information for interferon ß-1b, otherwise known as Betaseron, in the treatment of relapsing multiple sclerosis, according to manufacturer Bayer.

In addition to observational studies submitted to the FDA, Bayer also provided data from its global and US pharmacovigilance database of IFN-ß, which included prospective data over several years on the risk of IFN-ß for women who were, or were planning to become, pregnant. Those data showed a similar rate of birth defects and spontaneous abortions in those exposed to IFN-β in comparison with available general population worldwide estimates.

In NeurologyLive’s latest Peer Exchange, “Chronic Migraine New Paradigms in Management,” episode 4 has premiered. In this episode, several migraine experts comment on the changes that occur in the brain during aura and the role of glutamate as a target, the involvement of the trigeminal vascular system, and the defective interaction of systems during migraine.

Let’s take a look.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.

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