Med Device: FDA Approves First Device to Prevent Migraines

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Migraine sufferers who cannot tolerate available medications for preventing migraines or treating attacks now have an alternative in the form of a plastic headband that sends electronic pulses under the skin. The FDA recently approved Cefaly, from Belgium-based CEFALY Technology, as the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

Cefaly is a small, plastic, battery-powered device that attaches to the center of the forehead using a self-adhesive electrode that generates an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve. The device, only available via prescription and indicated for patients ages 18 and older, should only be used once daily for 20 minutes.

DC Dispatch: Effort to Ban Zohydro Goes to the Hill

Efforts to overturn the FDA’s approval of Zogenix’s Zohydro ER just keep escalating and the latest attempt involves legislation designed to force the drug off the market. Zohydro was approved by the FDA in October 2013 despite an advisory committee’s recommendation against it because it is a hydrocodone-based pain medication that lacks abuse-deterrent characteristics. However, the FDA approved it anyway for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

Since then, several groups, including a coalition of doctors, lawmakers, addiction specialists and law enforcement experts calling themselves Fed Up!, have been trying to get the FDA to overturn its decision. Then last month, both Sen. Charles E. Schumer (D-NY) and Sen. Joe Manchin (D-WV) sent letters to Health and Human Services (HHS) chief Kathleen Sebelius asking to remove the drug from the market. And a couple of weeks later, Manchin went a step further and introduced the Act to Ban Zohydro to the U.S. Senate which calls for the withdrawal of Zohydro and for the FDA to not approve any new applications for “pure hydrocodone bitartrate extended-release capsules” lacking abuse-deterrent qualities. According to Regulatory Focus, if passed this would be the first time an act of Congress overturns the FDA.

Therapeutic Talk: Continuous Monitoring Prevents Second Strokes

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Atrial fibrillation (AF), a symptomless cardiac arrhythmia, can often go undetected. However, the ability to properly diagnose AF would make it easier to prevent strokes as patients with the condition are five times more likely to have a stroke, according to a study published in Stroke.

Medtronic recently released the results from the CRYSTAL AF (CRYptogenic STrokeAnd underLying Atrial Fibrillation) Clinical Trial, which found that continuous cardiac monitoring with the Reveal XT Insertable Cardiac Monitor (ICM) discovered AF in 6.4 times more patients than standard care (including electrocardiograms, Holter monitors, etc.) over a six-month period. The trial focused on detecting AF in patients who had strokes of undetermined causes (cryptogenic strokes). In the study, 79% of the first AF episodes detected had no symptoms, and over a longer 36-month period the Reveal ICM detected AF in 8.8 times more patients than standard care.

“These study results should make us reconsider how we approach cryptogenic stroke patients,” Richard A. Bernstein, MD, professor of neurology in the Davee Department of Neurology at Northwestern University and director of the Stroke Program at Northwestern Memorial Hospital in Chicago, and member of the CRYSTAL AF steering committee, said in a statement. “We know patients with cryptogenic stroke are at an increased risk for a subsequent stroke, and finding AF allows us to put patients on medication that should be more effective at preventing these second strokes.”

Discoveries/Innovations: Repairing the Brain Through the Tongue

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Most people are familiar with the tongue. After all, you couldn’t savor your favorite meal without it or express verbally just how much you enjoyed it. But did you know it could also serve as a gateway to the brain and may be a key to the treatment of several neurological disorders?

Researchers at the U.S. Army Medical Research and Materiel Command (USAMRMC), in collaboration with the University of Wisconsin-Madison and NeuroHabilitation Corporation, discovered that thousands of tiny nerve endings located on the tongue may be used to help restore lost physical and mental function, according to the USAMRMC’s public affairs department. This is potentially great news for both service members and civilians who suffered a traumatic brain injury or stroke, or who have Parkinson’s or multiple sclerosis.

The treatment uses an electrode-covered oral device called a “PoNS,” a battery-operated appliance placed on the tongue that sends specially-patterned nerve impulses to the brain. This stimulation therapy, called cranial nerve non-invasive neuromodulation (aka CN-NiNM), typically lasts between 20 and 30 minutes and is accompanied by physical, occupational and cognitive exercises that are based on each patient’s deficits. The idea is based on a rapidly growing area of brain research called neuroplasticity, which proposes that the brain is not hardwired or fixed and can be reorganized in order to allow the patient to regain neural control.

The PoNS prototype and therapy were developed by UW-Madison scientists Yuri Danilov, PhD; Mitchell Tyler, MS, PE; and Kurt Kaczmarek, PhD, while NeuroHabilitation Corporation is funding the commercial development of the device. Montel Williams, a celebrity and military veteran who was diagnosed with multiple sclerosis in 1999, helped create NeuroHabilitation Corporation after he read about the research being done at UW-Madison and later joined a study at UW-Madison’s Tactile Communication & Neurorehabilitation Lab.

Currently, additional testing is underway with researchers and clinicians at the Blanchfield Army Community Hospital in Fort Campbell, KY, and more testing is being planned for at other Veteran facilities and civilian medical institutions as well as environmental testing to better understand the device’s limitations. Once all tests have been completed the USAMRMC will seek approval from the FDA.

FDA Update

Fast Track Designation

The FDA granted Fast Track designation to Edison Pharmaceuticals’ EPI-743, the company’s lead drug for the treatment of Friedreich’s ataxia. This is an autosomal recessive nuclear DNA inherited mitochondrial disease affecting an estimated one in 50,000 individuals in the U.S. and Europe. No FDA approved treatments currently exist for Friedreich’s ataxia.

Bioequivalence and Bioavailability Clarification

A new draft guidance, Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications, recommends various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. The guidance clarifies several items including that those applying for abbreviated new drug applications (ADNA) need to submit BE studies based on one cohort of patients who fasted before taking a drug and another who were fed, while full new drug applications (NDA) and investigational new drug (IND) applicants only need to submit data from a fasting study.

2015 Budget Calls for Small Increases

The Obama Administration’s proposed budget for the 2015 Fiscal Year calls for the FDA to receive $2.6 billion in appropriated funding and an additional $2.1 billion in funding from user fees, such as those paid by pharma and medical device companies to submit marketing applications. FDA budget expert Steven Grossman, JD, of the Alliance for a Stronger FDA told Regulatory Focus that while the proposal is a positive for the agency, with an appropriated budget growth of 1% overall and pharma and biological programs growing by about 2%, he still thinks the “FDA will need a larger appropriation to carry out its activities in FY 2015.”

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